21 C.F.R. Appendix B to Subpart B of Part 26—Scope of Product Coverage
Title 21 - Food and Drugs
1. Initial Coverage of the Transition Period Upon entry into force of this subpart as described in §26.80 (it is understood that the date of entry into force will not occur prior to June 1, 1998, unless the parties decide otherwise), products qualifying for the transitional arrangements under this subpart include: a. All Class I products requiring premarket evaluations in the United States—see Table 1. b. Those Class II products listed in Table 2. 2. During the Transition Period The parties will jointly identify additional product groups, including their related accessories, in line with their respective priorities as follows: a. Those for which review may be based primarily on written guidance which the parties will use their best efforts to prepare expeditiously; and b. Those for which review may be based primarily on international standards, in order for the parties to gain the requisite experience. The corresponding additional product lists will be phased in on an annual basis. The parties may consult with industry and other interested parties in determining which products will be added. 3. Commencement of the Operational Period a. At the commencement of the operational period, product coverage shall extend to all Class I/II products covered during the transition period. b. FDA will expand the program to categories of Class II devices as is consistent with the results of the pilot, and with FDA's ability to write guidance documents if the device pilot for the third party review of medical devices is successful. The MRA will cover to the maximum extent feasible all Class II devices listed in Table 3 for which FDA-accredited third party review is available in the United States. 4. Unless explicitly included by joint decision of the parties, this part does not cover any U.S. Class II-tier 3 or any Class III product under either system. [The lists of medical devices included in these tables are subject to change as a result of the Food and Drug Administration Modernization Act of 1997.] [63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]
Title 21: Food and Drugs
PART 26—MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
Subpart B—Specific Sector Provisions for Medical Devices
Appendix B to Subpart B of Part 26—Scope of Product Coverage
Table 1_Class I Products Requiring Premarket Evaluations in the UnitedStates, Included in Scope of Product Coverage at Beginning of Transition Period\1\------------------------------------------------------------------------ 21 CFR Section No. Regulation Name------------------------------------------------------------------------ Product Code_Device Name------------------------------------------------------------------------Anesthesiology Panel (21 CFR Part 868) 868.1910 Esophageal Stethoscope BZW_Stethoscope, Esophageal 868.5620 Breathing Mouthpiece BYP_Mouthpiece, Breathing 868.5640 Medicinal Nonventilatory Nebulizer (Atomizer) CCQ_Nebulizer, Medicinal, Nonventilatory (Atomizer) 868.5675 Rebreathing Device BYW_Device, Rebreathing 868.5700 Nonpowered Oxygen Tent FOG_Hood, Oxygen, Infant BYL_Tent, Oxygen 868.6810 Tracheobronchial Suction Catheter BSY_Catheters, Suction, TracheobronchialCardiovascular Panel (None)Dental Panel (21 CFR Part 872) 872.3400 Karaya and Sodium Borate With or Without Acacia Denture Adhesive KOM_Adhesive, Denture, Acacia and Karaya With Sodium Borate 872.3700 Dental Mercury (U.S.P.) ELY_Mercury 872.4200 Dental Handpiece and Accessories EBW_Controller, Food, Handpiece and Cord EFB_Handpiece, Air-Powered, Dental EFA_Handpiece, Belt and/or Gear Driven, Dental EGS_Handpiece, Contra- and Right- Angle Attachment, Dental EKX_Handpiece, Direct Drive, AC- Powered EKY_Handpiece, Water-Powered 872.6640 Dental Operative Unit and Accessories EIA_Unit, Operative DentalEar, Nose, and Throat Panel (21 CFR Part 874) 874.1070 Short Increment Sensitivity Index (SISI) Adapter ETR_Adapter, Short Increment Sensitivity Index (SISI) 874.1500 Gustometer ETM_Gustometer 874.1800 Air or Water Caloric Stimulator KHH_Stimulator, Caloric-Air ETP_Stimulator, Caloric-Water 874.1925 Toynbee Diagnostic Tube ETK_Tube, Toynbee Diagnostic 874.3300 Hearing Aid LRB_Face Plate Hearing-Aid ESD_Hearing-aid, Air-Conduction 874.4100 Epistaxis Balloon EMX_Balloon, Epistaxis 874.5300 ENT Examination and Treatment Unit ETF_Unit, Examining/Treatment, ENT 874.5550 Powered Nasal Irrigator KMA_Irrigator, Powered Nasal 874.5840 Antistammering Device KTH_Device, Anti-StammeringGastroenterology_Urology Panel (21 CFR Part 876) 876.5160 Urological Clamp for Males FHA_Clamp, Penile 876.5210 Enema Kit FCE_Kit, Enema, (for Cleaning Purpose) 876.5250 Urine Collector and Accessories FAQ_Bag, Urine Collection, Leg, for External UseGeneral Hospital Panel (21 CFR Part 880) 880.5270 Neonatal Eye Pad FOK_Pad, Neonatal Eye 880.5420 Pressure Infusor for an I.V. Bag KZD_Infusor, Pressure, for I.V. Bags 880.5680 Pediatric Position Holder FRP_Holder, Infant Position 880.6250 Patient Examination Glove LZB_Finger Cot FMC_Glove, Patient Examination LYY_Glove, Patient Examination, Latex LZA_Glove, Patient Examination, Poly LZC_Glove, Patient Examination, Speciality LYZ_Glove, Patient Examination, Vinyl 880.6375 Patient Lubricant KMJ_Lubricant, Patient 880.6760 Protective Restraint BRT_Restraint, Patient, Conductive FMQ_Restraint, ProtectiveNeurology Panel (21 CFR Part 882) 882.1030 Ataxiagraph GWW_Ataxiagraph 882.1420 Electroencephalogram (EEG) Signal Spectrum Analyzer GWS_Analyzer, Spectrum, Electroencephalogram Signal 882.4060 Ventricular Cannula HCD_Cannula, Ventricular 882.4545 Shunt System Implantation Instrument GYK_Instrument, Shunt System Implantation 882.4650 Neurosurgical Suture Needle HAS_Needle, Neurosurgical Suture 882.4750 Skull Punch GXJ_Punch, SkullObstetrics and Gynecology Panel (None)Ophthalmology Panel (21 CFR Part 886) 886.1780 Retinoscope HKM_Retinoscope, Battery-Powered 886.1940 Tonometer Sterilizer HKZ_Sterilizer, Tonometer 886.4070 Powered Corneal Burr HQS_Burr, Corneal, AC-Powered HOG_Burr, Corneal, Battery- Powered HRG_Engine, Trephine, Accessories, AC-Powered HFR_Engine, Trephine, Accessories, Battery-Powered HLD_Engine, Trephine, Accessories, Gas-Powered 886.4370 Keratome HNO_Keratome, AC-Powered HMY_Keratome, Battery-Powered 886.5850 Sunglasses (Nonprescription) HQY_Sunglasses (Nonprescription Including Photosensitive)Orthopedic Panel (21 CFR Part 888) 888.1500 Goniometer KQX_Goniometer, AC-Powered 888.4150 Calipers for Clinical Use KTZ_CaliperPhysical Medicine Panel (21 CFR Part 890) 890.3850 Mechanical Wheelchair LBE_Stroller, Adaptive IOR_Wheelchair, Mechanical 890.5180 Manual Patient Rotation Bed INY_Bed, Patient Rotation, Manual 890.5710 Hot or Cold Disposable Pack IMD_Pack, Hot or Cold, DisposableRadiology Panel (21 CFR Part 892) 892.1100 Scintillation (Gamma) Camera IYX_Camera, Scintillation (Gamma) 892.1110 Positron Camera IZC_Camera, Positron 892.1300 Nuclear Rectilinear Scanner IYW_Scanner, Rectilinear, Nuclear 892.1320 Nuclear Uptake Probe IZD_Probe, Uptake, Nuclear 892.1330 Nuclear Whole Body Scanner JAM_Scanner, Whole Body, Nuclear 892.1410 Nuclear Electrocardiograph Synchronizer IVY_Synchronizer, Electrocardiograph, Nuclear 892.1890 Radiographic Film Illuminator IXC_Illuminator, Radiographic- Film JAG_Illuminator, Radiographic- Film, Explosion-Proof 892.1910 Radiographic Grid IXJ_Grid, Radiographic 892.1960 Radiographic Intensifying Screen EAM_Screen, Intensifying, Radiographic 892.1970 Radiographic ECG/Respirator Synchronizer IXO_Synchronizer, ECG/Respirator, Radiographic 892.5650 Manual Radionuclide Applicator System IWG_System, Applicator, Radionuclide, ManualGeneral and Plastic Surgery Panel (21 CFR Part 878) 878.4200 Introduction/Drainage Catheter and Accessories KGZ_Accessories, Catheter GCE_Adaptor, Catheter FGY_Cannula, Injection GBA_Catheter, Balloon Type GBZ_Catheter, Cholangiography GBQ_Catheter, Continuous Irrigation GBY_Catheter, Eustachian, General & Plastic Surgery JCY_Catheter, Infusion GBX_Catheter, Irrigation GBP_Catheter, Multiple Lumen GBO_Catheter, Nephrostomy, General & Plastic Surgery GBN_Catheter, Pediatric, General & Plastic Surgery GBW_Catheter, Peritoneal GBS_Catheter, Ventricular, General & Plastic Surgery GCD_Connector, Catheter GCC_Dilator, Catheter GCB_Needle, Catheter 878.4320 Removable Skin Clip FZQ_Clip, Removable (Skin) 878.4460 Surgeon's Gloves KGO_Surgeon's Gloves 878.4680 Nonpowered, Single Patient, Portable Suction Apparatus GCY_Apparatus, Suction, Single Patient Use, Portable, Nonpowered 878.4760 Removable Skin Staple GDT_Staple, Removable (Skin) 878.4820 AC-Powered, Battery-Powered, and Pneumatically Powered Surgical Instrument Motors and Accessories/Attachments GFG_Bit, Surgical GFA_Blade, Saw, General & Plastic Surgery DWH_Blade, Saw, Surgical, Cardiovascular BRZ_Board, Arm (With Cover) GFE_Brush, Dermabrasion GFF_Bur, Surgical, General & Plastic Surgery KDG_Chisel (Osteotome) GFD_Dermatome GFC_Driver, Surgical, Pin GFB_Head, Surgical, Hammer GEY_Motor, Surgical Instrument, AC-Powered GET_Motor, Surgical Instrument, Pneumatic Powered DWI_Saw, Electrically Powered KFK_Saw, Pneumatically Powered HAB_Saw, Powered, and Accessories 878.4960 Air or AC-Powered Operating Table and Air or AC-Powered Operating Chair & Accessories GBB_Chair, Surgical, AC-Powered FQO_Table, Operating-Room, AC- Powered GDC_Table, Operating-Room, Electrical FWW_Table, Operating-Room, Pneumatic JEA_Table, Surgical with Orthopedic Accessories, AC- Powered 880.5090 Liquid Bandage KMF_Bandage, Liquid------------------------------------------------------------------------\1\Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA's Internet Web Site at http://www.fda.gov/cdrh/prodcode.php.
Table 2_Class II Medical Devices Included in Scope of Product Coverage at Beginning of Transition Period (United States to develop guidance documents identifying U.S. requirements and European Community (EC) to identify standards needed to meet EC requirements)\1\------------------------------------------------------------------------ Panel 21 CFR Section Regulation Name---------------- No. -------------------------------------- ------------------ Product Code_Device Name------------------------------------------------------------------------ RA 892.1000 Magnetic Resonance Diagnostic Device ................ MOS_COIL, Magnetic Resonance, Specialty ................ LNH_System, Nuclear Magnetic Resonance Imaging ................ LNI_System, Nuclear Magnetic Resonance SpectroscopicDiagnostic Ultrasound: RA 892.1540 Nonfetal Ultrasonic Monitor ................ JAF_Monitor, Ultrasonic, Nonfetal RA 892.1550 Ultrasonic Pulsed Doppler Imaging System ................ IYN_System, Imaging, Pulsed Doppler, Ultrasonic RA 892.1560 Ultrasonic Pulsed Echo Imaging System ................ IYO_System, Imaging, Pulsed Echo, Ultrasonic RA 892.1570 Diagnostic Ultrasonic Transducer ................ ITX_Transducer, Ultrasonic, DiagnosticDiagnostic X- Ray Imaging Devices (except mammographic x- ray systems): RA 892.1600 Angiographic X-Ray System ................ IZI_System, X-Ray, Angiographic RA 892.1650 Image-Intensified Fluoroscopic X-Ray System ................ MQB_Solid State X-Ray Imager (Flat Panel/Digital Imager) ................ JAA_System, X-Ray, Fluoroscopic, Image-Intensified RA 892.1680 Stationary X-Ray System ................ KPR_System, X-Ray, Stationary RA 892.1720 Mobile X-Ray System ................ IZL_System, X-Ray, Mobile RA 892.1740 Tomographic X-Ray System ................ IZF_System, X-Ray, Tomographic RA 892.1750 Computed Tomography X-Ray System ................ JAK_System, X-Ray, Tomography, ComputedECG-Related Devices: CV 870.2340 Electrocardiograph ................ DPS_Electrocardiograph ................ MLC_Monitor, ST Segment CV 870.2350 Electrocardiograph Lead Switching Adaptor ................ DRW_Adaptor, Lead Switching, Electrocardiograph CV 870.2360 Electrocardiograph Electrode ................ DRX_Electrode, Electrocardiograph CV 870.2370 Electrocardiograph Surface Electrode Tester ................ KRC_Tester, Electrode, Surface, Electrocardiographic NE 882.1400 Electroencephalograph ................ GWQ_Electroencephalograph HO 880.5725 Infusion Pump (external only) ................ MRZ_Accessories, Pump, Infusion ................ FRN_Pump, Infusion ................ LZF_Pump, Infusion, Analytical Sampling ................ MEB_Pump, Infusion, Elastomeric ................ LZH_Pump, Infusion, Enteral ................ MHD_Pump, Infusion, Gallstone Dissolution ................ LZG_Pump, Infusion, Insulin ................ MEA_Pump, Infusion, PCAOphthalmic Instruments: OP 886.1570 Ophthalmoscope ................ HLI_Ophthalmoscope, AC-Powered ................ HLJ_Ophthalmoscope, Battery-Powered OP 886.1780 Retinoscope ................ HKL_Retinoscope, AC-Powered OP 886.1850 AC-Powered Slit-Lamp Biomicroscope ................ HJO_Biomicroscope, Slit-Lamp, AC- Powered OP 886.4150 Vitreous Aspiration and Cutting Instrument ................ MMC_Dilator, Expansive Iris (Accessory) ................ HQE_Instrument, Vitreous Aspiration and Cutting, AC-Powered ................ HKP_Instrument, Vitreous Aspiration and Cutting, Battery-Powered ................ MLZ_Vitrectomy, Instrument Cutter OP 886.4670 Phacofragmentation System ................ HQC_Unit, Phacofragmentation SU 878.4580 Surgical Lamp ................ HBI_Illuminator, Fiberoptic, Surgical Field ................ FTF_Illuminator, Nonremote ................ FTG_Illuminator, Remote ................ HJE_Lamp, Fluorescein, AC-Powered ................ FQP_Lamp, Operating-Room ................ FTD_Lamp, Surgical ................ GBC_Lamp, Surgical, Incandescent ................ FTA_Light, Surgical, Accessories ................ FSZ_Light, Surgical, Carrier ................ FSY_Light, Surgical, Ceiling Mounted ................ FSX_Light, Surgical, Connector ................ FSW_Light, Surgical, Endoscopic ................ FST_Light, Surgical, Fiberoptic ................ FSS_Light, Surgical, Floor Standing ................ FSQ_Light, Surgical, Instrument NE 882.5890 Transcutaneous Electrical Nerve Stimulator for Pain Relief ................ GZJ_Stimulator, Nerve, Transcutaneous, For Pain Relief ................ Noninvasive Blood Pressure Measurement Devices: CV 870.1120 Blood Pressure Cuff ................ DXQ_Cuff, Blood-Pressure CV 870.1130 Noninvasive Blood Pressure Measurement System (except nonoscillometric) ................ DXN_System, Measurement, Blood- Pressure, Noninvasive HO 880.6880 Steam Sterilizer (greater than 2 cubic feet) ................ FLE_Sterilizer, SteamClinical Thermometers: HO 880.2910 Clinical Electronic Thermometer (except tympanic or pacifier) ................ FLL_Thermometer, Electronic, Clinical AN 868.5630 Nebulizer ................ CAF_Nebulizer (Direct Patient Interface)Hypodermic Needles and Syringes (except antistick and self- destruct): HO 880.5570 Hypodermic Single Lumen Needle ................ MMK_Container, Sharpes ................ FMI_Needle, Hypodermic, Single Lumen ................ MHC_Port, Intraosseous, Implanted HO 880.5860 Piston Syringe ................ FMF_Syringe, PistonSelected Dental Materials: DE 872.3060 Gold-Based Alloys and Precious Metal Alloys for Clinical Use ................ EJT_Alloy, Gold Based, For Clinical Use ................ EJS_Alloy, Precious Metal, For Clinical Use DE 872.3200 Resin Tooth Bonding Agent ................ KLE_Agent, Tooth Bonding, Resin DE 872.3275 Dental Cement ................ EMA_Cement, Dental ................ EMB_Zinc Oxide Eugenol DE 872.3660 Impression Material ................ ELW_Material, Impression DE 872.3690 Tooth Shade Resin Material ................ EBF_Material, Tooth Shade, Resin DE 872.3710 Base Metal Alloy ................ EJH_Metal, BaseLatex Condoms: OB 884.5300 Condom ................ HIS_Condom------------------------------------------------------------------------\1\Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA's Internet Web Site at http://www.fda.gov/cdrh/prodcode.php.
Table 3_Medical Devices for Possible Inclusion in Scope of Product Coverage During Operational Period\1\------------------------------------------------------------------------ Product Family 21 CFR Section No Device Name Tier------------------------------------------------------------------------Anesthesiology Panel Anesthesia 868.5160 Gas machine for 2 Devices anesthesia or analgesia 868.5270 Breathing system 2 heater 868.5440 Portable oxygen 2 generator 868.5450 Respiratory gas 2 humidifier 868.5630 Nebulizer 2 868.5710 Electrically 2 powered oxygen tent 868.5880 Anesthetic 2 vaporizer Gas Analyser 868.1040 Powered 2 Algesimeter 868.1075 Argon gas 2 analyzer 868.1400 Carbon dioxide 2 gas analyzer 868.1430 Carbon monoxide 2 gas analyzer 868.1500 Enflurane gas 2 analyzer 868.1620 Halothane gas 2 analyzer 868.1640 Helium gas 2 analyzer 868.1670 Neon gas 2 analyzer 868.1690 Nitrogen gas 2 analyzer 868.1700 Nitrous oxide 2 gas analyzer 868.1720 Oxygen gas 2 analyzer 868.1730 Oxygen uptake 2 computer Peripheral 868.2775 Electrical 2 Nerve peripheral Stimulators nerve stimulator Respiratory 868.1750 Pressure 2 Monitoring plethysmograph 868.1760 Volume 2 plethysmograph 868.1780 Inspiratory 2 airway pressure meter 868.1800 Rhinoanemometer 2 868.1840 Diagnostic 2 spirometer 868.1850 Monitoring 2 spirometer 868.1860 Peak-flow meter 2 for spirometry 868.1880 Pulmonary- 2 function data calculator 868.1890 Predictive 2 pulmonary- function value calculator 868.1900 Diagnostic 2 pulmonary- function interpretation calculator 868.2025 Ultrasonic air 2 embolism monitor 868.2375 Breathing 2 frequency monitor (except apnea detectors) 868.2480 Cutaneous carbon 2 dioxide (PcCO2) monitor 868.2500 Cutaneous oxygen 2 monitor (for an infant not under gas anesthesia) 868.2550 Pneumotachomomet 2 er 868.2600 Airway pressure 2 monitor 868.5665 Powered 2 percussor 868.5690 Incentive 2 spirometer Ventilator 868.5905 Noncontinuous 2 ventilator (IPPB) 868.5925 Powered 2 emergency ventilator 868.5935 External 2 negative pressure ventilator 868.5895 Continuous 2 ventilator 868.5955 Intermittent 2 mandatory ventilation attachment 868.6250 Portable air 2 compressorCardiovascular Panel Cardiovascula 870.1425 Programmable 2 r Diagnostic diagnostic computer 870.1450 Densitometer 2 870.2310 Apex cardiograph 2 (vibrocardiogra ph) 870.2320 Ballistocardiogr 2 aph 870.2340 Electrocardiogra 2 ph 870.2350 Electrocardiogra 1 ph lead switching adaptor 870.2360 Electrocardiogra 2 ph electrode 870.2370 Electrocardiogra 2 ph surface electrode tester 870.2400 Vectorcardiograp 1 h 870.2450 Medical cathode- 1 ray tube display 870.2675 Oscillometer 2 870.2840 Apex 2 cardiographic transducer 870.2860 Heart sound 2 transducer Cardiovascula ................. Valve, pressure r Monitoring relief, cardiopulmonary bypass 870.1100 Blood pressure 2 alarm 870.1110 Blood pressure 2 computer 870.1120 Blood pressure 2 cuff 870.1130 Noninvasive 2 blood pressure measurement system 870.1140 Venous blood 2 pressure manometer 870.1220 Electrode 2 recording catheter or electrode recording probe 870.1270 Intracavitary 2 phonocatheter system 870.1875 Stethoscope 2 (electronic) 870.2050 Biopotential 2 amplifier and signal conditioner 870.2060 Transducer 2 signal amplifier and conditioner 870.2100 Cardiovascular 2 blood flow- meter 870.2120 Extravascular 2 blood flow probe 870.2300 Cardiac monitor 2 (including cardiotachomete r and rate alarm) 870.2700 Oximeter 2 870.2710 Ear oximeter 2 870.2750 Impedance 2 phlebograph 870.2770 Impedance 2 plethysmograph 870.2780 Hydraulic, 2 pneumatic, or photoelectric plethysmographs 870.2850 Extravascular 2 blood pressure transducer 870.2870 Catheter tip 2 pressure transducer 870.2880 Ultrasonic 2 transducer 870.2890 Vessel occlusion 2 transducer 870.2900 Patient 2 transducer and electrode cable (including connector) 870.2910 Radiofrequency 2 physiological signal transmitter and receiver 870.2920 Telephone 2 electrocardiogr aph transmitter and receiver 870.4205 Cardiopulmonary 2 bypass bubble detector 870.4220 Cardiopulmonary 2 bypass heart- lung machine console 870.4240 Cardiovascular 2 bypass heat exchanger 870.4250 Cardiopulmonary 2 bypass temperature controller 870.4300 Cardiopulmonary 2 bypass gas control unit 870.4310 Cardiopulmonary 2 bypass coronary pressure gauge 870.4330 Cardiopulmonary 2 bypass on-line blood gas monitor 870.4340 Cardiopulmonary 2 bypass level sensing monitor and/or control 870.4370 Roller-type 2 cardiopulmonary bypass blood pump 870.4380 Cardiopulmonary 2 bypass pump speed control 870.4410 Cardiopulmonary 2 bypass in-line blood gas sensor Cardiovascula 870.5050 Patient care 2 r suction Therapeutic apparatus 870.5900 Thermal 2 regulation system Defibrillator 870.5300 DC-defibrillator 2 (including paddles) 870.5325 Defibrillator 2 tester Echocardiogra 870.2330 Echocardiograph 2 ph Pacemaker 870.1750 External 2 & programmable Accessories pacemaker pulse generator 870.3630 Pacemaker 2 generator function analyzer 870.3640 Indirect 2 pacemaker generator function analyzer 870.3720 Pacemaker 2 electrode function tester Miscellaneous 870.1800 Withdrawal- 2 infusion pump 870.2800 Medical magnetic 2 tape recorder None Batteries, rechargeable, class II devicesDental Panel Dental 872.1720 Pulp tester 2 Equipment 872.1740 Caries detection 2 device 872.4120 Bone cutting 2 instrument and accessories 872.4465 Gas-powered jet 2 injector 872.4475 Spring-powered 2 jet injector 872.4600 Intraoral 2 ligature and wire lock 872.4840 Rotary scaler 2 872.4850 Ultrasonic 2 scaler 872.4920 Dental 2 electrosurgical unit and accessories 872.6070 Ultraviolet 2 activator for polymerization 872.6350 Ultraviolet 2 detector Dental 872.3050 Amalgam alloy 2 Material 872.3060 Gold-based 2 alloys and precious metal alloys for clinical use 872.3200 Resin tooth 2 bonding agent 872.3250 Calcium 2 hydroxide cavity liner 872.3260 Cavity varnish 2 872.3275 Dental cement 2 (other than zinc oxide- eugenol) 872.3300 Hydrophilic 2 resin coating for dentures 872.3310 Coating material 2 for resin fillings 872.3590 Preformed 2 plastic denture tooth 872.3660 Impression 2 material 872.3690 Tooth shade 2 resin material 872.3710 Base metal alloy 2 872.3750 Bracket adhesive 2 resin and tooth conditioner 872.3760 Denture 2 relining, repairing, or rebasing resin 872.3765 Pit and fissure 2 sealant and conditioner 872.3770 Temporary crown 2 and bridge resin 872.3820 Root canal 2 filling resin (other than chloroform use) 872.3920 Porcelain tooth 2 Dental X-ray 872.1800 Extraoral source 2 x-ray system 872.1810 Intraoral source 2 x-ray system Dental 872.4880 Intraosseous 2 Implants fixation screw or wire 872.3890 Endodontic 2 stabilizing splint Orthodontic 872.5470 Orthodontic 2 plastic bracketEar/Nose/Throat Panel Diagnostic 874.1050 Audiometer 2 Equipment 874.1090 Auditory 2 impedance tester 874.1120 Electronic noise 2 generator for audiometric testing 874.1325 Electroglottogra 2 ph 874.1820 Surgical nerve 2 stimulator/ locator Hearing Aids 874.3300 Hearing aid (for 2 bone- conduction) 874.3310 Hearing aid 2 calibrator and analysis system 874.3320 Group hearing 2 aid or group auditory trainer 874.3330 Master hearing 2 aid Surgical 874.4250 Ear, nose, and 1 Equipment throat electric or pneumatic surgical drill 874.4490 Argon laser for 2 otology, rhinology, and laryngology 874.4500 Ear, nose, and 2 throat microsurgical carbon dioxide laserGastroenterology/ Urology Panel Endoscope 876.1500 Endoscope and 2 (including accessories angioscopes, laparscopes, ophthalmic endoscopes) 876.4300 Endoscopic 2 electrosurgical unit and accessories Gastroenterol 876.1725 Gastrointestinal 1 ogy motility monitoring system Hemodialysis 876.5600 Sorbent 2 regenerated dialysate delivery system for hemodialysis 876.5630 Peritoneal 2 dialysis system and accessories 876.5665 Water 2 purification system for hemodialysis 876.5820 Hemodialysis 2 system and accessories 876.5830 Hemodialyzer 2 with disposable insert (kiil- type) Lithotriptor 876.4500 Mechanical 2 lithotriptor Urology 876.1620 Urodynamics 2 Equipment measurement system 876.5320 Nonimplanted 2 electrical continence device 876.5880 Isolated kidney 2 perfusion and transport system and accessoriesGeneral Hospital Panel Infusion 880.2420 Electronic 2 Pumps and monitor for Systems gravity flow infusion systems 880.2460 Electrically 2 powered spinal fluid pressure monitor 880.5430 Nonelectrically 2 powered fluid injector 880.5725 Infusion pump 2 Neonatal 880.5400 Neonatal 2 Incubators incubator 880.5410 Neonatal 2 transport incubator 880.5700 Neonatal 2 phototherapy unit Piston 880.5570 Hypodermic 1 Syringes single lumen needle 880.5860 Piston syringe 1 (except antistick) 880.6920 Syringe needle 2 introducer Miscellaneous 880.2910 Clinical 2 electronic thermometer 880.2920 Clinical mercury 2 thermometer 880.5100 AC-powered 1 adjustable hospital bed 880.5500 AC-powered 2 patient lift 880.6880 Steam sterilizer 2 (greater than 2 cubic feet)Neurology Panel 882.1020 Rigidity 2 analyzer 882.1610 Alpha monitor 2 Neuro- 882.1320 Cutaneous 2 Diagnostic electrode 882.1340 Nasopharyngeal 2 electrode 882.1350 Needle electrode 2 882.1400 Electroencephalo 2 graph 882.1460 Nystagmograph 2 882.1480 Neurological 2 endoscope 882.1540 Galvanic skin 2 response measurement device 882.1550 Nerve conduction 2 velocity measurement device 882.1560 Skin potential 2 measurement device 882.1570 Powered direct- 2 contact temperature measurement device 882.1620 Intracranial 2 pressure monitoring device 882.1835 Physiological 2 signal amplifier 882.1845 Physiological 2 signal conditioner 882.1855 Electroencephalo 2 gram (EEG) telemetry system 882.5050 Biofeedback 2 device Echoencephalo 882.1240 Echoencephalogra 2 graphy ph RPG 882.4400 Radiofrequency 2 lesion generator Neuro Surgery none Electrode, 2 spinal epidural 882.4305 Powered compound 2 cranial drills, burrs, trephines, and their accessories 882.4310 Powered simple 2 cranial drills burrs, trephines, and their accessories 882.4360 Electric cranial 2 drill motor 882.4370 Pneumatic 2 cranial drill motor 882.4560 Stereotaxic 2 instrument 882.4725 Radiofrequency 2 lesion probe 882.4845 Powered rongeur 2 882.5500 Lesion 2 temperature monitor Stimulators 882.1870 Evoked response 2 electrical stimulator 882.1880 Evoked response 2 mechanical stimulator 882.1890 Evoked response 2 photic stimulator 882.1900 Evoked response 2 auditory stimulator 882.1950 Tremor 2 transducer 882.5890 Transcutaneous 2 electrical nerve stimulator for pain reliefObstetrics/ Gynecology Panel Fetal 884.1660 Transcervical 2 Monitoring endoscope (amnioscope) and accessories 884.1690 Hysteroscope and 2 accessories (for performance standards) 884.2225 Obstetric- 2 gynecologic ultrasonic imager 884.2600 Fetal cardiac 2 monitor 884.2640 Fetal 2 phonocardiograp hic monitor and accessories 884.2660 Fetal ultrasonic 2 monitor and accessories 884.2675 Fetal scalp 1 circular (spiral) electrode and applicator 884.2700 Intrauterine 2 pressure monitor and accessories 884.2720 External uterine 2 contraction monitor and accessories 884.2740 Perinatal 2 monitoring system and accessories 884.2960 Obstetric 2 ultrasonic transducer and accessories Gynecological 884.1720 Gynecologic 2 Surgery laparoscope and Equipment accessories 884.4160 Unipolar 2 endoscopic coagulator- cutter and accessories 884.4550 Gynecologic 2 surgical laser 884.4120 Gynecologic 2 electrocautery and accessories 884.5300 Condom 2 Ophthalmic 886.3320 Eye sphere 2 Implants implant Contact Lens 886.1385 Polymethylmethac 2 rylate (PMMA) diagnostic contact lens 886.5916 Rigid gas 2 permeable contact lens (daily wear only) Diagnostic 886.1120 Opthalmic camera 1 Equipment 886.1220 Corneal 1 electrode 886.1250 Euthyscope (AC- 1 powered) 886.1360 Visual field 1 laser instrument 886.1510 Eye movement 1 monitor 886.1570 Ophthalmoscope 1 886.1630 AC-powered 1 photostimulator 886.1640 Ophthalmic 1 preamplifier 886.1670 Ophthalmic 2 isotope uptake probe 886.1780 Retinoscope (AC- 1 powered device) 886.1850 AC-powered slit 1 lamp biomicroscope 886.1930 Tonometer and 2 accessories 886.1945 Transilluminator 1 (AC-powered device) 886.3130 Ophthalmic 2 conformer (Diagnostic/ 886.4670 Phacofragmentati 2 Surgery on system Equipment) Ophthalmic 886.3340 Extraocular 2 Implants orbital implant 886.3800 Scleral shell 2 Surgical 880.5725 Infusion pump 2 Equipment (performance standards) 886.3100 Ophthalmic 2 tantalum clip 886.3300 Absorbable 2 implant (scleral buckling method) 886.4100 Radiofrequency 2 electrosurgical cautery apparatus 886.4115 Thermal cautery 2 unit 886.4150 Vitreous 2 aspiration and cutting instrument 886.4170 Cryophthalmic 2 unit 886.4250 Ophthalmic 1 electrolysis unit (AC- powered device) 886.4335 Operating 1 headlamp (AC- powered device) 886.4390 Ophthalmic laser 2 886.4392 Nd:YAG laser for 2 posterior capsulotomy 886.4400 Electronic metal 1 locator 886.4440 AC-powered 1 magnet 886.4610 Ocular pressure 2 applicator 886.4690 Ophthalmic 2 photocoagulator 886.4790 Ophthalmic 2 sponge 886.5100 Ophthalmic beta 2 radiation source none Ophthalmoscopes, 1 replacement batteries, hand- heldOrthopedic Panel Implants 888.3010 Bone fixation 2 cerclage 888.3020 Intramedullary 2 fixation rod 888.3030 Single/multiple 2 component metallic bone fixation appliances and accessories 888.3040 Smooth or 2 threaded metallic bone fixation fastener 888.3050 Spinal 2 interlaminal fixation orthosis 888.3060 Spinal 2 intervertebral body fixation orthosis Surgical 888.1240 AC-powered 2 Equipment dynamometer 888.4580 Sonic surgical 2 instrument and accessories/ attachments none Accessories, 2 fixation, spinal interlaminal none Accessories, 2 fixation, spinal intervertebral body none Monitor, 1 pressure, intracompartmen tal none Orthosis, 2 fixation, spinal intervertebral fusion none Orthosis, spinal pedicle fixation none System, cement 1 removal extractionPhysical Medicine Panel Diagnostic 890.1225 Chronaximeter 2 Equipment or (Therapy) Therapeutic Equipment 890.1375 Diagnostic 2 electromyograph 890.1385 Diagnostic 2 electromyograph needle electrode 890.1450 Powered reflex 2 hammer 890.1850 Diagnostic 2 muscle stimulator or (Therapy) 890.5850 Powered muscle 2 stimulator Therapeutic 890.5100 Immersion 2 Equipment hydrobath 890.5110 Paraffin bath 2 890.5500 Infrared lamp 2 890.5720 Water 2 circulating hot or cold pack 890.5740 Powered heating 2 padRadiology Panel MRI 892.1000 Magnetic 2 resonance diagnostic device Ultrasound 884.2660 Fetal ultrasonic 2 Diagnostic monitor and accessories 892.1540 Nonfetal ultrasonic monitor 892.1560 Ultrasonic 2 pulsed echo imaging system 892.1570 Diagnostic 2 ultrasonic transducer 892.1550 Ultrasonic pulsed doppler imaging system Angiographic 892.1600 Angiographic x- 2 ray system Diagnostic X- 892.1610 Diagnostic x-ray 2 Ray beam-limiting device 892.1620 Cine or spot 2 fluorographic x- ray camera 892.1630 Electrostatic x- 2 ray imaging system 892.1650 Image- 2 intensified fluoroscopic x- ray system 892.1670 Spot film device 2 892.1680 Stationary x-ray 2 system 892.1710 Mammographic x- 2 ray system 892.1720 Mobile x-ray 2 system 892.1740 Tomographic x- 1 ray system 892.1820 Pneumoencephalog 2 raphic chair 892.1850 Radiographic 1 film cassette 892.1860 Radiographic 1 film/cassette changer 892.1870 Radiographic 2 film/cassette changer programmer 892.1900 Automatic 2 radiographic film processor 892.1980 Radiologic table 1 CT Scanner 892.1750 Computed 2 tomography x- ray system Radiation 892.5050 Medical charged- 2 Therapy particle radiation therapy system 892.5300 Medical neutron 2 radiation therapy system 892.5700 Remote 2 controlled radionuclide applicator system 892.5710 Radiation 2 therapy beam- shaping block 892.5730 Radionuclide 2 brachytherapy source 892.5750 Radionuclide 2 radiation therapy system 892.5770 Powered 2 radiation therapy patient support assembly 892.5840 Radiation 2 therapy simulation system 892.5930 Therapeutic x- 1 ray tube housing assembly Nuclear 892.1170 Bone 2 Medicine densitometer 892.1200 Emission 2 computed tomography system 892.1310 Nuclear 1 tomography system 892.1390 Radionuclide 2 rebreathing systemGeneral/Plastic Surgery Panel Surgical 878.4630 Ultraviolet lamp 2 Lamps for dermatologic disorders 890.5500 Infrared lamp 2 878.4580 Surgical lamp 2 Electrosurgic 878.4810 Laser surgical 2 al Cutting instrument for Equipment use in general and plastic surgery and in dermatology 878.4400 Electrosurgical 2 cutting and coagulation device and accessories Miscellaneous 878.4780 Powered suction 2 pump------------------------------------------------------------------------\1\Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA's Internet Web Site at http://www.fda.gov/cdrh/prodcode.php.
