FDA Product Classification Codes Begining with "U"
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| FDA Device Classification |
Medical Specialty |
FDA Product Code |
FDA Regulation Number |
Device Class |
510k Exempt? |
| U.V. LIGHT, TLC |
Clinical Toxicology |
DJS |
862.2270 |
1 |
Y |
| U.V. METHOD, CPK ISOENZYMES |
Clinical Chemistry |
JHW |
862.1215 |
2 |
N |
| U.V. METHOD, GALACTOSE |
Clinical Chemistry |
JIB |
862.1310 |
1 |
N |
| U.V. SPECTROMETRY, CARBAMAZEPINE |
Clinical Toxicology |
LDB |
862.3645 |
2 |
N |
| U.V. SPECTROMETRY, DIPHENYLHYDANTOIN |
Clinical Toxicology |
LDC |
862.3350 |
2 |
N |
| U.V. SPECTROMETRY, PHENOBARBITAL |
Clinical Toxicology |
LDA |
862.3660 |
2 |
N |
| U.V. SPECTROMETRY, PRIMIDONE |
Clinical Toxicology |
LCZ |
862.3680 |
2 |
N |
| U.V. SPECTROMETRY, THEOPHYLLINE |
Clinical Toxicology |
LCY |
862.3880 |
2 |
N |
| U.V. SPECTROMETRY, TRICYCLIC ANTIDEPRESSANT DRUGS |
Clinical Toxicology |
LFH |
862.3910 |
2 |
N |
| ULTRASOUND, THROMBOLYSIS SYSTEM |
General Plastic Surgery |
NJP |
|
|
N |
| UNIT, ACTIVATION, BREATH CONTROL |
Physical Medicine |
LFF |
|
|
N |
| UNIT, AIRFLOW, LAMINAR |
General Plastic Surgery |
FLJ |
878.5070 |
2 |
N |
| UNIT, BETA, RADIATION, OPHTHALMIC |
Opthalmic |
HRL |
886.5100 |
2 |
N |
| UNIT, CAUTERY, THERMAL, AC-POWERED |
Opthalmic |
HQO |
886.4115 |
2 |
N |
| UNIT, CAUTERY, THERMAL, BATTERY-POWERED |
Opthalmic |
HQP |
886.4115 |
2 |
N |
| UNIT, CHILLING |
Physical Medicine |
IMF |
890.5940 |
1 |
Y |
| UNIT, CRYOPHTHALMIC |
Opthalmic |
HPS |
886.4170 |
2 |
N |
| UNIT, CRYOPHTHALMIC, AC-POWERED |
Opthalmic |
HRN |
886.4170 |
2 |
N |
| UNIT, CRYOSURGICAL, ACCESSORIES |
General Plastic Surgery |
GEH |
878.4350 |
2 |
N |
| UNIT, CRYOTHERAPY, OPHTHALMIC |
Opthalmic |
HQA |
886.4170 |
2 |
N |
| UNIT, DRYING |
Clinical Chemistry |
JRJ |
862.2050 |
1 |
Y |
| UNIT, ELECTROLYSIS, AC-POWERED, OPHTHALMIC |
Opthalmic |
HRO |
886.4250 |
2 |
N |
| UNIT, ELECTROLYSIS, BATTERY-POWERED, OPHTHALMIC |
Opthalmic |
HPY |
886.4250 |
1 |
Y |
| UNIT, ELECTROSURGICAL |
Gastroenterology/Urology |
FAR |
876.4300 |
2 |
N |
| UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES |
General Plastic Surgery |
BWA |
878.4400 |
2 |
N |
| UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL |
Dental |
EKZ |
872.4920 |
2 |
N |
| UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) |
Gastroenterology/Urology |
KNS |
876.4300 |
2 |
N |
| UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES), REPROCESSED |
Gastroenterology/Urology |
NLR |
876.4300 |
2 |
N |
| UNIT, EXAMINING/TREATMENT, ENT |
Ear, Nose, Throat |
ETF |
874.5300 |
1 |
Y |
| UNIT, FILTER, MEMBRANE |
Clinical Chemistry |
JRL |
862.2050 |
1 |
Y |
| UNIT, FLUIDOTHERAPY |
Physical Medicine |
LSB |
|
|
N |
| UNIT, HEATING, POWERED |
Physical Medicine |
IRQ |
890.5950 |
1 |
Y |
| UNIT, ISOLATION, SURGICAL |
General Plastic Surgery |
FRT |
878.5070 |
2 |
N |
| UNIT, LIQUID-OXYGEN, PORTABLE |
Anesthesiology |
BYJ |
868.5655 |
2 |
N |
| UNIT, NEONATAL PHOTOTHERAPY |
General Hospital |
LBI |
880.5700 |
2 |
N |
| UNIT, OPERATIVE DENTAL |
Dental |
EIA |
872.6640 |
1 |
N |
| UNIT, ORAL IRRIGATION |
Dental |
EFS |
872.6510 |
1 |
Y |
| UNIT, PHACOFRAGMENTATION |
Opthalmic |
HQC |
886.4670 |
2 |
N |
| UNIT, SUCTION OPERATORY |
Dental |
EBR |
872.6640 |
1 |
Y |
| UNIT, SYRINGE, AIR AND/OR WATER |
Dental |
ECB |
872.4565 |
1 |
Y |
| UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING |
Orthopedic |
HSR |
888.5890 |
1 |
Y |
| UNIT, ULTRAVIOLET SANITATION/STERILIZATION (FOR TOOTHBRUSHES), NON-STERILE |
Dental |
NOB |
872.6855 |
1 |
Y |
| UNIT, ULTRAVIOLET SANITATION/STERILIZATION (FOR TOOTHBRUSHES), STERILE |
Dental |
MCF |
872.6855 |
1 |
Y |
| UNIT, WRIST, EXTERNAL LIMB COMPONENT, MECHANICAL |
Physical Medicine |
ISZ |
890.3420 |
1 |
Y |
| UNIT, WRIST, EXTERNAL LIMB COMPONENT, POWERED |
Physical Medicine |
KGH |
890.3420 |
1 |
Y |
| UNIT, X-RAY, EXTRAORAL WITH TIMER |
Dental |
EHD |
872.1800 |
2 |
N |
| UNIT, X-RAY, INTRAORAL |
Dental |
EAP |
872.1810 |
2 |
N |
| URANYL ACETATE/ZINC ACETATE, SODIUM |
Clinical Chemistry |
CEI |
862.1665 |
2 |
N |
| UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN |
Clinical Chemistry |
CDQ |
862.1770 |
2 |
N |
| UREASE, PHOTOMETRIC, UREA NITROGEN |
Clinical Chemistry |
CDN |
862.1770 |
2 |
N |
| URETEROSCOPE |
Gastroenterology/Urology |
FGB |
876.1500 |
2 |
N |
| URETHROMETER |
Gastroenterology/Urology |
FBR |
876.5520 |
1 |
Y |
| URETHROSCOPE |
Gastroenterology/Urology |
FGC |
876.1500 |
2 |
N |
| URETHROTOME |
Gastroenterology/Urology |
EZO |
876.4770 |
2 |
N |
| URIDINE-5-DIPHOSPHOGLUCOSE, NAD (U.V.), ALPHA-D GALACTOSE-1-PHOSPHATE |
Clinical Chemistry |
JLJ |
862.1315 |
2 |
N |
| URINAL |
General Hospital |
FNP |
880.6730 |
1 |
Y |
| URINALYSIS CONTROLS (ASSAYED AND UNASSAYED) |
Clinical Chemistry |
JJW |
862.1660 |
1 |
N |
| URINARY CARBOHYDRATE ANALYSIS KIT |
Clinical Chemistry |
MPG |
862.1505 |
1 |
Y |
| URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM |
Clinical Chemistry |
LPS |
862.1377 |
2 |
N |
| URINOMETER, ELECTRICAL |
Gastroenterology/Urology |
EXS |
876.1800 |
2 |
Y |
| URINOMETER, MECHANICAL |
Gastroenterology/Urology |
EXR |
876.1800 |
2 |
Y |
| UROFLOWMETER |
Gastroenterology/Urology |
EXY |
876.1800 |
2 |
Y |
| UTENSIL, EATING |
Physical Medicine |
ILC |
890.5050 |
1 |
Y |
| UTENSIL, HOMEMAKING |
Physical Medicine |
IKW |
890.5050 |
1 |
Y |
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