ATTACHMENT
A
CLASS I DEVICES EXEMPT FROM MOST OF THE QS/GMP REQUIREMENTS BY
CLASSIFICATION REGULATIONS
THE FOLLOWING LIST OF EXEMPTED CLASS I DEVICES IS ARRANGED IN PRODUCT
CODE SEQUENCE.TO USE THIS LIST CONSULT THE KEY WORD LIST FOR DEVICES TO DETERMINE THE
PRODUCT CODE. THE KEY WORD LIST WAS FORMERLY INCLUDED IN THE EDRO DATA CODES
MANUAL (TN-84-1) AND WILL BE ON FILE IN THE DISTRICT'S REFERENCE FILE.ANESTHESIOLOGY DEVICES
(Final Regulation Published in July 16, 1982 FEDERAL REGISTER;
EFFECTIVE DATE: 8/16/82)
REGULATION
73 BTB HOOK, ETHER 868.542073 BXJ CLIP, NOSE 868.622573 BXL ALGESIMETER, MANUAL 868.103073 BYN CHAIR, POSTURE, FOR CARDIAC 868.536573 BYO BOTTLE, BLOW 868.522073 BYW REBREATHING DEVICE 868.567573 BZN CART, EMERGENCY, CARDIOPULMONARY 868.617573 CBG SPREADER, CUFF 868.576077 EPE BRUSH, CLEANING, TRACHEAL TUBE 868.579573 JFE VALVE, SWITCHING (PLOSS) 868.1965 CARDIOVASCULAR
74 --- (No devices have been exempted)CLINICAL CHEMISTRY DEVICES
(Final Regulation Published in May 1, 1987 FEDERAL REGISTER;
EFFECTIVE DATE: 7/30/87)
75 JBS TIMER, GENERAL LABORATORY 862.205075 JJP ION SELECTIVE ELECTRODES (NON-SPECIFIED) 862.205075 JQO ANALYTICAL BALANCE 862.2050 75 JQQ DIALYZER 862.2050 75 JQY PH METER 862.2050
75 JQZ POLARIMETER 862.2050 75 JRB MICRO MIXER 862.2050 75 JRG HEATING BLOCK 862.2050 75 JRJ DRYING UNIT 862.2050 75 JRK EVAPORATOR 862.2050 75 JRL MEMBRANE FILTER UNIT 862.2050 75 JRM FREEZER 862.205075 JRO BLENDER/MIXER 862.205075 JRQ SHAKER/STIRRER 862.205075 JRR TEMPERATURE REGULATOR 862.2050DENTAL DEVICES
(Final Regulation Published in August 12, 1987 FEDERAL REGISTER;
EFFECTIVE DATE: 9/11/87)
76 EBH MATERIAL IMPRESSION TRAY RESIN 872.3670
76 EEA BASE PLATE SHELLAC 872.6200
76 EEJ GUARD, DISK 872.6010
76 EFH PAPER, ARTICULATION 872.6140
76 EFW TOOTH BRUSH, MANUAL 872.6855
76 EFX PROTECTOR, SILICATE 872.6670
76 EGD INTRAORAL DENTAL WAX 872.6890
76 EGZ FILM, X-RAY HOLDER 872.1905
76 EHJ DISK, ABRASIVE 872.6010
76 EHK PROPHYLAXIS CUP 872.6290
76 EHL POINT, ABRASIVE 872.6010
76 EHM STRIP, POLISHING AGENT 872.6010
76 EHY TRAY, IMPRESSION, PREFORMED 872.6880
76 EIE DAM, RUBBER AND ACCESSORIES 872.6300
76 EJP ARTICULATOR 872.3150
76 EJQ WHEEL, POLISHING AGENT 872.6010
76 JET PICK, MASSAGING 872.6650
76 KCO TUBE IMPRESSION AND MATRIX 872.5220
76 KCR FACE BOW 872.3220
76 KCS PANTOGRAPH 872.3730
76 KHR SALIVA ABSORBER PAPER 872.6050
76 KMT DISPOSABLE FLUORIDE TRAY 872.6870
76 KXR RESIN APPLICATOR 872.4565
EAR, NOSE, AND THROAT DEVICES
(Final Regulation Published in November 6, 1986 FEDERAL REGISTER;
EFFECTIVE DATE: 12/8/86)
77 ESE LARYNX, ARTIFICIAL (BATTERY-POWERED) 874.3375
77 ETM GUSTOMETER 874.1500
77 JPN MANUAL NEBULIZER PUMP 874.5220
77 JXS BLOCK, CUTTING, ENT 874.3540
77 JXT CRIMPER, WIRE, ENT 874.3540
77 JXW DIE, WIRE BENDING, ENT 874.3540
77 JXX FORCEPS WIRE CLOSURE, ENT 874.3540
77 JXY JIG, PISTON CUTTING, ENT 874.3540
77 JXZ PUNCH, GELFOAM 874.3540
77 JYA SCISSORS, WIRE CUTTING, ENT 874.3540
77 JYB VISE, OSSICULAR FINGER 874.3540
77 KCL BLOWER, POWDER, ENT 874.5220
77 KCM DROPPER, ENT 874.5220
77 KCN EAR WICK 874.5220
77 KCO INHALER, NASAL 874.5220
GASTROENTEROLOGY-UROLOGY DEVICES
(Final Regulation Published in November 23, 1983 Federal Register;
EFFECTIVE DATE: 12/23/83)
78 EXI PASTE-ON DEVICE FOR INCONTINENCE 876.5250
78 EXJ DEVICE, INCONTINENCE, UROSHEATH TYPE 876.5250
78 EXN HERNIA SUPPORT 876.5970
78 EYQ PROTECTIVE GARMENT FOR INCONTINENCE 876.5920
78 EYT SHEATH, CORRUGATED RUBBER 876.5250
78 FAQ BAG, LEG (FOR EXTERNAL USE) 876.5250
78 FCE ENEMA KIT 876.5210
78 FFH COLLECTOR, URINE, PEDIATRIC 876.5250
78 KNX URINE COLLECTOR AND ACCESSORIES 876.5250
(not intended to be connected to an
indwelling catheter:
GENERAL AND PLASTIC SURGERY DEVICES
79 KCZ PROSTHESIS, BREAST, EXTERNAL 878.3800
GENERAL HOSPITAL AND PERSONAL USE DEVICES
(Final Regulation Published in October 21, 1980 Federal Register:
EFFECTIVE DATE: 11/20/80)
80 FLH SANITIZER, MECHANICAL 880.6800
80 FMA DEPRESSOR, TONGUE 880.6230
80 FME GOWN, EXAMINATION 880.6265
80 FMF NON-STERILE IRRIGATING SYRINGE (SYRINGE) 880.5860
80 FMH CONTAINER, SPECIMEN 880.6175
80 FML CHAIR, BLOOD DONOR (NON-WHEELED) 880.6140
80 FMP PROTECTOR, SKIN PRESSURE 880.6450
80 FMQ RESTRAINT PROTECTIVE 880.6760
80 FMR TRANSFER DEVICE, PATIENT, MANUAL 880.6785
80 FMW MATTRESS COVER (FOR MEDICAL PURPOSE) 880.6190
80 FNJ BED, MANUAL 880.5120
80 FNN NIPPLE, LAMBS FEEDING 880.5640
80 FNP URINAL 880.6730
80 FNS RING CUTTER 880.6200
80 FNY BASIN, EMESIS 880.6730
80 FOA BOARD, CARDIOPULMONARY 880.6080
80 FOB BEDPAN 880.6730
80 FOK PAD, NEONATAL EYE 880.6025
80 FOR NON-STERILE ABSORBENT TIPPED APPLICATOR 880.5270
80 FPF BOTTLE, HOT/COLD WATER 880.6085
80 FPP STRETCHER, HAND CARRIED 880.6900
80 FPS BOARD, BED 880.6070
80 FQA SCALE, SURGICAL SPONGE 880.2740
80 FQJ THERAPEUTIC SCROTAL SUPPORT 880.5820
80 FQK BINDER, PERINEAL 880.5160
80 FQL STOCKING, MEDICAL SUPPORT 880.5780
80 FQM BANDAGE, ELASTIC 880.5075
80 FRI SCALE, STAND-ON, PATIENT 880.2700
80 FRJ CHAIR, GERIATRIC (NON-WHEELED, NON-POWERED) 880.6140
80 FRK CHAIR, EXAMINATION, AND TREATMENT 880.6140
80 FRL MEDICAL ABSORBENT FIBER 880.5300
80 FRP PEDIATRIC POSITION HOLDER 880.5680
80 FSD BINDER, ABDOMINAL 880.5160
80 FSL STRETCHER, HAND CARRIED 880.6900
80 IKY NON-POWERED FLOTATION THERAPY MATTRESS 880.5150
80 KIA COVER, CAST 880.6185
80 KME MEDICAL DISPOSABLE BEDDING 880.6060
80 KMO BINDER, ELASTIC 880.5160
80 KYR BAG, ICE 880.6050
80 KYT BATTERY POWERED EXAM LIGHT 880.6350
80 KYW GRADUATED LIQUID MEDICATION 880.6430
80 KYX LIQUID MEDICATION DISPENSER 880.6430
80 LBJ VEIN STABILIZATION DEVICE 880.6980
IMMUNOLOGY DEVICES
82 --- (No devices have been exempted)
MICROBIOLOGY DEVICES
(Final Regulation Published in November 9, l982 FEDERAL REGISTER;
EFFECTIVE DATE: 12/9/82)
83 GMB LIGHT, WOOD'S FLUORESCENCE 866.2600
83 JTB MEDIA DISPENSING/STACKING DEVICES 866.2440
83 JTM ANAEROBIC GLOVE BOX 866.2120
83 JTQ INCUBATORS/WATER BATHS, ALL 866.2540
83 KZC MANUAL COLONY COUNTER 866.2180
NEUROLOGY DEVICES
(Final Regulation Published in September 4, 1979 FEDERAL REGISTER;
EFFECTIVE DATE: 10/4/79)
84 GWI TWO POINT DISCRIMINATOR 882.1200
84 GWX TUNING FORK 882.1525
84 GWZ PERCUSSOR 882.1700
84 GXB ESTHESIOMETER 882.1500
OBSTETRICAL/GYNECOLOGICAL
85 --- (No devices have been exempted)
OPHTHALMIC DEVICES
(Final Regulation Published in September 2, 1987 FEDERAL REGISTER;
EFFECTIVE DATE: 10/2/87)
86 HIT TESTER, COLOR VISION 886.1170
86 HJC OCULAR ESTHESIOMETER 886.1040
86 HJF MAGNIFIER, HAND-HELD, LOW-VISION 886.5540
86 HJH BINOCULAR LOUPE, LOW POWER 886.5120
86 HJI LENS, FUNDUS, HRUBY, DIAGNOSTIC 886.1395
86 HJJ LENS, FRESNEL, FLEXIBLE, DIAGNOSTIC 886.1390
86 HJL LENS, CONDENSING, DIAGNOSTIC 886.1380
86 HKB TELESCOPE, HAND-HELD, LOW-VISION 886.5870
86 HKC SPECTACLE MICROSCOPE, LOW-VISION 886.5540
86 HKD TAPE, NYSTAGMUS 886.1905
86 HKF MIRROR, HEADBAND, OPHTHALMIC 886.1500
86 HKG FORNISXCOPE 886.1320
86 HKK TELESCOPE, SPECTACLE, LOW-VISION 886.5870
86 HKM RETINOSCOPE, BATTERY-POWERED 886.1780
86 HKN REFRACTOR, MANUAL, NON-POWERED, 886.1770
86 HKQ PRISM, ROTARY, OPHTHALMIC 886.1665
86 HKR LENS, MADDOX 886.1400
86 HKT PRISM, FRESNEL, OPHTHALMIC 886.1655
86 HKW PRISM, BAR, OPHTHALMIC 886.1650
86 HLC INSTRUMENT, MEASURING, STEREOPSIS 886.1460
86 HLE RULER, NEAR POINT (PUNCTOMETER) 886.1790
86 HLH PUPILLOMETER, MANUAL 886.1700
86 HLJ OPHTHALMOSCOPE BATTERY-POWERED 886.1570
86 HLK SCREEN, TANGENT, TARGET 886.1810
BATTERY-POWERED
86 HLN GAUGE, LENS, OPHTHALMIC 886.1420
86 HLO TEST, SPECTACLE DISSOCIATION, 886.1910
BATTERY-POWERED
86 HLP TARGET, FUSION AND STEREOSCOPIC 886.1880
86 HLR KERATOSCOPE, BATTERY-POWERED 886.1350
86 HMD CHAIR, OPHTHALMIC, MANUAL 886.1140
86 HMG STAND, INSTRUMENT, OPHTHALMIC 886.1860
86 HMJ SCREEN, TANGENT, PROJECTION 886.1810
BATTERY-POWERED
86 HMM DISTOMETER 886.1190
86 HMQ MARKER, SCLERA 886.4570
86 HMR MARKER, OCULAR 886.4570
86 HMS DRUM, OPHTHALMIC KNIFE TEST 886.4230
86 HMX CANNULA, OPHTHALMIC 886.4350
86 HMZ TRABECULOTOME 886.4350
86 HNA SPUD, OPHTHALMIC 886.4350
86 HNB SPOON, OPHTHALMIC 886.4350
86 HNC SPECULA, OPHTHALMIC 886.4350
86 HND SPATULA, OPHTHALMIC 886.4350
86 HNE SNARE, ENUCLEATING 886.4350
86 HNF SCISSORS, OPHTHALMIC 886.4350
86 HNG RONGEUR, LACHRYMAL SAC 886.4350
86 HNH RING, OPHTHALMIC (FLIERINGA) 886.4350
86 HNI RETRACTOR, OPHTHALMIC 886.4350
86 HNJ PUNCH, CORNEO-SCLERAL 886.4350
86 HNK PROBE, TRABECULOTOMY 886.4350
86 HNL PROBE, LACHRYMAL 886.4350
86 HNM NEEDLE, OPHTHALMIC SUTURING 886.4350
86 HNN KNIFE, OPHTHALMIC 886.4350
86 HNP INTRODUCER, SPHERE 886.4350
86 HNQ HOOK, OPHTHALMIC 886.4350
86 HNR FORCEPS, OPHTHALMIC 886.4350
86 HNS EXPRESSOR 886.4350
86 HNT ERISOPHAKE 886.4350
86 HNW DILATOR, LACHRYMAL 886.4350
86 HNX DEPRESSOR, ORBITAL 886.4350
86 HNY CYSTOTOME 886.4350
86 HNZ CURETTE, OPHTHALMIC 886.4350
86 HOA COMPRESSOR, ORBITAL 886.4350
86 HOB CLAMP, MUSCLE, OPHTHALMIC 886.4350
86 HOC CLIP, IRIS RETRACTOR 886.4350
86 HOD CLAMP, EYELID, OPHTHALMIC 886.4350
86 HOE CALIPER, OPHTHALMIC 886.4350
86 HOF BURR, CORNEAL, MANUAL 886.4350
86 HOH SPECTACLE, OPERATING (LOUPE), 886.4770
OPHTHALMIC
86 HOI SPECTACLE, MAGNIFYING 886.5840
86 HOJ SCREEN, TANGENT, TARGET 886.1810
86 HOL SCREEN, TANGENT, FELT (CAMPIMETER) 886.1810
86 HON PERIMETER, MANUAL 886.1605
86 HOP CAMPIMETER, STEREO, BATTERY-POWERED 886.1810
86 HOQ GRID, AMSLER 886.1330
86 HOR SIMULITAN (INCLUDING CROSSED CYLINDER) 886.1840
86 HOT AID, VISION, IMAGE-INTENSIFICATION, 886.5910
BATTERY-POWERED
86 HOW DRUM, OPTOKINETIC 886.1200
86 HOX CHART, VISUAL ACUITY 886.1150
86 HOY SHIELD, EYE, OPHTHALMIC 886.4750
86 HPA FRAME, TRIAL, OPHTHALMIC 886.1415
86 HPB CLIP, LENS, TRIAL, OPHTHALMIC 886.1410
86 HPD LENS, BAGOLINI 886.1375
86 HPE AID, VISION, OPTICAL, BATTERY-POWERED 886.5915
86 HPN MAGNET, PERMANENT 886.4445
86 HRH TREPHINE, MANUAL, OPHTHALMIC 886.4350
86 HRK TABLE, INSTRUMENT, MANUAL, OPHTHALMIC 886.4855
ORTHOPEDIC DEVICES
(Final Regulation Published in September 4, 1987 FEDERAL REGISTER;
EFFECTIVE DATE: 10/5/87)
87 HST APPARATUS, TRACTION, NON-POWERED 888.5850
ORTHOPEDIC
87 JQZ TRACTION COMPONENT, NON-INVASIVE 862.2050
87 LGF CAST COMPONENT 888.5940
87 LGG MANUAL CAST APPLICATION AND REMOVAL 888.5980 INSTRUMENT
HEMATOLOGY AND PATHOLOGY DEVICES
(Final Regulation Published in September 12, 1980 FEDERAL
REGISTER;
EFFECTIVE DATE: 10/14/80)
88 GFR NEW METHYLENE BLUE STAIN 864.1850
88 GGD CRYSTAL VIOLET FOR HEMATOLOGY 864.1850
88 GGH IRON STAINS 864.1850
88 GGI PERIODIC ACID SCHIFF STAIN 864.1850
88 GHP BRILLIANT CRESYL BLUE 864.1850
88 GIX TOLUIDINE BLUE 864.1850
88 GJH RETICULOCYTE STAIN 864.1850
88 GJJ HEINZ BODY STAINS 864.1850
88 GJL ROMANOWSKY STAINS 864.1850
88 GJO SLIDES AND COVERSLIPS 864.3010
88 GJY MICROSCOPE 864.3600
88 GLP GIEMSA STAIN 864.1850
88 HYB EOSIN Y 864.1850
88 HYC FAST GREEN 864.1850
88 HYD FAST RED SALT B 864.1850
88 HYE FONTANNA SILVER SOLUTION 864.1850
88 HYH GOLD CHLORIDE 864.1850
88 HYI GRAMS IODINE 864.1850
88 HYJ HEMATOXYLIN 864.1850
88 HYK HEMATOXYLIN HARRIS'S 864.1850
88 HYL HEMATOXYLIN MAYER'S 864.1850
88 HYO HEMATOXYLIN WEIGERT'S 864.1850
88 HYQ IRON CHLORIDE-WEIGERT 864.1850
88 HYR LEUCO-PATENT BLUE 864.1850
88 HYS LIGHT GREEN 864.1850
88 HYW MALLORY'S TRICHROME STAIN 864.1850
88 HYY METANIL YELLOW 864.1850
88 HYZ METHENAMINE SILVER 864.1850
88 HZA METHYL GREEN 864.1850
88 HZC MUCICARMINE 864.1850
88 HZD MULLER'S COLLOIDAL IRON 864.1850
88 HZE NILE BLUE 864.1850
88 HZF NUCLEAR FAST RED 864.1850
88 HZG OIL RED O 864.1850
88 HZH ORANGE G 864.1850
88 HZJ PAPANICOLAOU STAIN 864.1850
88 HZL PHLOXINE B 864.1850
88 HZM PHOSPHOTUNGSTIC ACID HEMATOXYLIN 864.1850
88 HZN PICRO METHYL BLUE 864.1850
88 HZO PONCEAU STAIN 864.1850
88 HZP PYRONIN 864.1850
88 HZQ RED VIOLET - LB 864.1850
88 HZR RESORCIN FUCHSIN 864.1850
88 HZS SAFRANIN 864.1850
88 HZT SCHIFF REAGENT 864.1850
88 HZX SILVER NITRATE 864.1850
88 HZY SIRIUS RED 864.1850
88 HZZ SUDAN BLACK B 864.1850
88 IAA TITAN YELLOW 864.1850
88 IAB TOLUIDINE BLUE 864.1850
88 IAC VAN GIESON'S STAIN 864.1850
88 IAD VAN GIESON'S PICRO-FUCHSIN 864.1850
88 IAE WEIGERT'S IRON HEMATOXYLIN 864.1850
88 IAF WRIGHT'S STAIN 864.1850
88 IAM LUGOL'S SOLUTION 864.4010
88 IAT APATHY'S GUM SYRUP 864.4010
88 IAW COLLODION 864.4010
88 IBJ ICROSCOPE, LIGHT 864.3600
88 IBK MICROSCOPE, FLUORESCENCE/UV 864.3600
88 IBL MICROSCOPE, INVERTED STAGE, TISSUE 864.3600
CULTURE
88 IBM MICROSCOPE, PHASE CONTRAST 864.3600
88 ICC EOSIN B 864.1850
88 ICD DARROW RED 864.1850
88 ICF CRYSTAL VIOLET FOR HISTOLOGY 864.1850
88 ICG CRESYL VIOLET ACETATE 864.1850
88 ICH CONGO RED 864.1850
88 ICI CHROME ALUM HEMATOXYLIN 864.1850
88 ICL CARBOL FUCHSIN 864.1850
88 ICM BRILLIANT YELLOW 864.1850
88 ICN BIEBRICH SCARLET 864.1850
88 ICO BEST'S CARMINE 864.1850
88 ICQ AZURE A 864.1850
88 ICR AZOCARMINE B 864.1850
88 ICS AZOCARMINE G 864.1850
88 ICT AZAN COUNTERSTAIN 864.1850
88 ICX ANILINE 864.1850
88 ICY ANILINE ACID FUCHSIN 864.1850
88 ICZ AMMONIACAL SILVER HYDROXIDE 864.1850
SILVER NITRATE
88 IDA ALCIAN BLUE 864.1850
88 IDB ALDEHYDE FUCHSIN 864.1850
88 IDC ACRIDINE ORANGE 864.1850
88 IDD ALIZARIN RED 864.1850
88 IDE ACID HEMATEIN 864.1850
88 IDF ACID FUCHSIN 864.1850
88 IDL MICROTOME, ACCESSORIES 864.3010
88 IDM MICROTOME, ULTRA 864.3010
88 IDN MICROTOME, FREEZING ATTACHMENT 864.3010
88 IDO MICROTOME, ROTARY 864.3010
88 IDP MICROTOME, CRYOSTAT 864.3010
88 IDQ INFILTRATOR 864.3010
88 IDR OVENS, PARAFFIN 864.3010
88 IDS MELTING POT, PARAFFIN 864.3010
88 IDT MELTING POINT APPARATUS, PARAFFIN 864.3010
88 IDW DISPENSERS, PARAFFIN 864.3010
88 IDX SIEVES, TISSUE 864.3010
88 IDY FLOTATION BATHS, TISSUE 864.3010
88 IDZ CASSETTES, TISSUE 864.3010
88 IEG TABLE, SLIDE WARMING 864.3010
88 IEH LAMPS, SLIDE WARMING 864.3010
88 IER OLYETHYLENE GLYCOL (CARBOWAX) 864.4010
88 IEX GELATIN 864.4010
88 IEZ CELLOIDIN 864.4010
88 IFF DECALCIFIER SOLUTION, ELECTROLYTIC 864.4010
88 IFH ZENKER'S SOLUTION 864.4010
88 IFI SPRAYS, SYNTHETIC, SMEAR 864.4010
88 IFJ RICHARDSON GLYCOL FIXATIVE 864.4010
88 IFL POLETHYLENE GLYCOL PRESERVATIVE 864.4010
88 IFN ORTH'S SOLUTION 864.4010
88 IFO NEWCOMER'S SOLUTION 864.4010
88 IFP FORMALIN, NEUTRAL BUFFERED 864.4010
88 IFQ MERCURIC CHLORIDE FORMULATIONS 864.4010
88 IFS HELLY SOLUTION 864.4010
88 IFZ GELATIN FOR SPECIMEN ADHESION 864.4010
88 IGB FORMALIN-SODIUM ACETATE SOLUTION 864.4010
88 IGC FORMALIN-SALINE 864.4010
88 IGD FORMOL CALCIUM SOLUTION 864.4010
88 IGE FORMALIN AMMONIUM BROMIDE 864.4010
88 IGF FORMALIN-ALCOHOL-ACETIC ACID 864.4010
88 IGG FORMALDHYDE (FORMALIN, FORMOL) 864.4010
88 IGK CLARKE'S SOLUTION 864.4010
88 IGM CARNOY'S SOLUTION 864.4010
88 IGN BOUIN'S FLUID 864.4010
88 IHJ BLENDORS FOR SPUTUM 864.3010
88 IJZ CLEARING OIL 864.4010
88 JCC PH BUFFERS 864.4010
88 JCE ISOTONIC SOLUTION 864.4010
88 JCH ESTERASE 864.1850
88 JCI ACID PHOSPHATASE, CYTOCHEMICAL 864.1850
88 JTS STAINS, MICROBIOLOGIC, ALL 864.1850
88 KDX DECALCIFIER SOLUTION, ACID CONTAINING 864.4010
88 KDY CHELATING AGENTS FOR DECALIFICATION 864.4010
88 KDZ DEALCIFIER DEVICES, ELECTROLYTIC 864.3010
88 KEE OSMIUM TETROXIDE 864.4010
88 KEF PARAFORMALDEHYDE 864.4010
88 KEG LAMPS, MICROSCOPE 864.4010
88 KEH MICROMETERS, MICROSCOPE 864.3600
88 KEI CONDENSERS, MICROSCOPE 864.3600
88 KEJ STAGES, MICROSCOPE 864.3600
88 KEL ALBUMIN-BASED ADHESIVES 864.4010
88 KEM CLEARING AGENTS 864.4010
88 KEO PARAFFIN, ALL FORMULATIONS 864.4010
88 KEP OIL SOLUBLE MOUNTING MEDIA 864.4010
88 KEQ WATER SOLUBLE MOUNTING MEDIA 864.4010
88 KER EMBEDDING CONTAINER 864.3010
88 KES COVERSLIPS, MICROSCOPE SLIDE 864.3010
88 KET FILTER, CELL COLLECTION, TISSUE 864.3010
88 KEW SLIDES, MICROSCOPE 864.3010
88 KFC METHYLENE BLUE, TISSUE STAIN 864.1850
88 KFD ANILINE BLUE 864.1850
88 KFE NEUTRAL RED 864.1850
88 KFL MICROTOME, SLIDING 864.3010
88 KIY CHAMBER, SLIDE CULTURE 864.2240
88 KIZ DISH, TISSUE CULTURE 864.2240
88 KJA FLASK, TISSUE CULTURE 864.2240
88 KJB ROLLER APPARATUS 864.2240
88 KJC ROLLER BOTTLE, TISSUE CULTURE 864.2240
88 KJD SPINNER FLASK 864.2240
88 KJE SPINNER SYSTEM, CELL CULTURE 864.2240
88 KJF SUSPENSION SYSTEM, CELL CULTURE 864.2240
88 KJG TUBE, TISSUE CULTURE 864.3010
88 KJH PERFUSION APPARATUS 864.2240
88 KJK AURAMINE O 864.1850
88 KJL AZURE C 864.1850
88 KJM BISMARCK BROWN Y 864.1850
88 KJN BRILLIANT CRESYL BLUE 864.1850
88 KJO BRILLIANT GREEN 864.1850
88 KJP CARMINE 864.1850
88 KJQ CHLORAZOL BLACK E 864.1850
88 KJR ERYTHROSIN B 864.1850
88 KJS ETHYL EOSIN 864.1850
88 KJT INDIGOCARMINE 864.1850
88 KJW JANUS GREEN B 864.1850
88 KJX JENNER STAIN 864.1850
88 KJY MALACHITE GREEN 864.1850
88 KJZ MARTIUS YELLOW 864.1850
88 KKA METHYL ORANGE 864.1850
88 KKB METHYL VIOLET 2B 864.1850
88 KKC METHYLENE VIOLET 864.1850
88 KKD NIGROSIN 864.1850
88 KKE ORANGE II 864.1850
88 KKF ORCEIN 864.1850
88 KKG PROTARGOL S 864.1850
88 KKH RESAUZRIN TABLET 864.1850
88 KKI ROSE BENGAL 864.1850
88 KKJ SUDAN III 864.1850
88 KKK SUDAN IV 864.1850
88 KKL THIONIN 864.1850
88 KKM METHYLENE BLUE THIOCYANATE 864.1850
88 KKP SILVER CARBONATE SOLUTION 864.1850
88 KKQ SODIUM PERIODATE 864.1850
88 KKR POTASSIUM PERIODATE 864.1850
88 KKS PERIODIC ACID 864.1850
88 KKT HEMATOXYLIN EHRLICH'S 864.1850
88 KKW BASIC FUCHSIN 864.1850
88 KQD HEMATOLOGY STAINS 864.4010
PHYSICAL MEDICINE DEVICES
(Final Regulation Published in November 23, 1983 Federal Register;
EFFECTIVE DATE: 12/23/83)
89 IKW UTENSIL, HOMEMAKING 890.5050
89 IKX AID, TRANSFER 890.5050
89 ILC UTENSIL, EATING 890.5050
89 ILD ADAPTOR, DRESSING 890.5050
89 ILE SLING, ARM, OVERHEAD SUPPORTED 890.3475
89 ILG STOCKING, ELASTIC 890.3475
89 ILH SPLINT, HAND, AND COMPONENTS 890.3475
89 ILI SLING, ARM 890.3640
89 ILP SYSTEM, COMMUNICATION, NON-POWERED 890.3700
89 ILS ADAPTOR, HYGIENE 890.5050
89 ILT ADAPTOR, RECREATIONAL 890.5050
89 ILW ADAPTOR, GROOMING 890.5050
89 ILZ ACCESSORIES, TRACTION 890.5925
89 IMA HEAT PACK, MOIST 890.5730
89 IME PACK, HOT OR COLD, REUSABLE 890.5700
89 IMS SUPPORT, HEAD AND TRUNK, WHEELCHAIR 890.3910
89 IMX BOARD, LAP, WHEELCHAIR 890.3910
89 IMY ARMBOARD, WHEELCHAIR 890.3910
89 IMZ HOLDER, CRUTCH AND CANE, WHEELCHAIR 890.3910
89 INC CUFF, PUSHER, WHEELCHAIR 890.3910
89 INE SLING, OVERHEAD SUSPENSION, WHEELCHAIR 890.3910
89 INF SCALE, PLATFORM, WHEELCHAIR 890.3940
89 INP TIPS AND PADS, CANE, CRUTCH AND WALKER 890.3790
89 INT PLINTH 890.3520
89 IOD COMPONENTS, EXERCISE 890.5350
89 IOE BARS, PARALLEL, EXERCISE 890.5370
89 IOG TREADMILL, MECHANICAL 890.5370
89 ION EXERCISER, NON-MEASURING 890.5370
89 IOY SUPPORT, ARM 890.3475
89 IOZ SPLINT, ABDUCTION, CONGENITAL HIP 890.3665
DISLOCATION
89 IPG SHOE, CAST 890.3025
89 IPM COVER, LIMB 890.3025
89 IPR CRUTCH 890.3150
89 IPS CANE 890.3075
89 IPT ORTHOSIS, THORACIC 890.3490
89 IPW ORTHOSIS, SACROILIAC, SOFT 890.3490
89 IPX ORTHOSIS, RIB FRACTURE, SOFT 890.3490
89 IPY ORTHOSIS, LUMBO-SACRAL 890.3490
89 IQE ORTHOSIS, LUMBAR 890.3490
89 IQF ORTHOSIS, CERVICAL-THORACIC, RIGID 890.3490
89 IQG ADAPTOR, HOLDER, SYRINGE 890.5050
89 IQI ORTHOSIS, LIMB BRACE 890.3475
89 IQJ SPLINT, CLAVICLE 890.3490
89 IQK ORTHOSIS, CERVICLE 890.3490
89 IQM SPLINT, TEMPORARY, TRAINING 890.3025
89 IQO DEVICE, PROSTHESIS ALIGNMENT 890.3025
89 IQP ROTATOR, TRANSVERSE 890.3025
89 IQQ JOINT, SHOULDER, EXTERNAL LIMB COMPONENT 890.3420
89 IQW HOOK, EXTERNAL LIMB COMPONENT, POWERED 890.3420
89 IQX HOOK, EXTERNAL LIMB COMPONENT, MECHANICAL 890.3420
89 IQZ HAND, EXTERNAL LIMB COMPONENT, POWERED 890.3420
89 IRA HAND, EXTERNAL LIMB COMPONENT, MECHANICAL 890.3420
89 IRD JOINT, ELBOW, EXTERNAL LIMB COMPONENT, 890.3420
MECHANICAL
89 IRE JOINT, ELBOW, EXTERNAL LIMB COMPONENT, 890.3420
POWERED
89 ISH ANKLE/FOOT, EXTERNAL LIMB COMPONENT 890.3420
89 ISL JOINT, HIP, EXTERNAL LIMB COMPONENT 890.3420
89 ISM PYLON, POST SURGICAL 890.3025
89 ISN CABLE 890.3420
89 ISP VALVE, PROSTHESIS 890.3420
89 ISR BAND OR BELT, PELVIC SUPPORT 890.3425
89 ISS PROSTHESIS, THIGH SOCKET, EXTERNAL 890.3420
COMPONENT
89 ISY JOINT, KNEE, EXTERNAL LIMB COMPONENT 890.3420
89 ISZ UNIT, WRIST, EXTERNAL LIMB COMPONENT, 890.3420
MECHANICAL
89 ITC STIRRUP, EXTERNAL BRACE COMPONENT 890.3410
89 ITG BANDAGE, CAST 890.3025
89 ITJ WALKER, MECHANICAL 890.3825
89 ITM CAGE, KNEE 890.3475
89 ITN SPLINT, DENIS BROWN 890.3675
89 ITO TWISTER, BRACE SETTING 890.3410
89 ITQ JOINT, KNEE, EXTERNAL BRACE 890.3475
89 ITS JOINT, HIP, EXTERNAL BRACE 890.3475
89 ITW JOINT, ANKLE, EXTERNAL BRACE 890.3475
89 KGH UNIT, WRIST, EXTERNAL LIMB COMPONENT, 890.3420
POWERED
89 KHY CANE, SAFETY WALK 890.3075
89 KND ACCESSORIES, WHEELCHAIR 884.5390
89 KNL BOARD, SCOOTER, PRONE 890.5370
89 KNP ORTHOSIS, CORRECTIVE SHOE 890.3475
89 KTZ BATH, SITZ, NON-POWERED 888.4150
RADIOLOGICAL DEVICES
(Final Regulation Published in January 20, 1988 FEDERAL REGISTER;
EFFECTIVE DATE: 2/19/88)
90 IWY HOLDER, HEAD, RADIOGRAPHIC 892.1920
90 IXF TEST PATTERN, RADIOGRAPHIC 892.1940
90 IXG PHANTOM, ANTHROPOMORPHIC, RADIOGRAPHIC 892.1950
CLINICAL TOXICOLOGY DEVICES
(Final Regulation Published in May 1, 1987 FEDERAL REGISTER;
EFFECTIVE DATE: 7/30/87)
91 DJS UV LIGHT, TLC 862.2270
91 DKK DEVELOPING TANKS, TLC 862.2270
91 DLC ATOMIZER, TLC 862.2270
91 DPA THIN LAYER CHROMATOGRAPHY, APPARATUS, 862.2270
GENERAL USE |
