U.S. OPHTHALMIC, L.L.C.

Address:9990 NW 14 St Unit 105,Doral,FL,33172,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Otoscope (ERA) (4) Perimeter, Automatic, Ac-Powered (HPT) (2) Retinoscope, Battery-Powered (HKM) (2) Speculum, Ent (EPY) (1) Refractometer, Ophthalmic (HKO) (1) Ophthalmoscope, Battery-Powered (HLJ) (1) Refractor, Manual, Non-Powered, Including Phoropter (HKN) (1)

Premarket Exempt

No Yes

Clear

Eli Ezer - 00851158007409 Catalog Number :

Device Description : Ezer Fiber Otoscope

Device Class : 1

Duns Number: 166760392

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

Eli Ezer - 00851158007416 Catalog Number :

Device Description : Ophthalmoscope and Otoscope Diagnostic Set, 2 Pcs AA handle and Zipper Bag Halogen

Device Class : 1

Duns Number: 166760392

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

Eli Ezer - 00851158007423 Catalog Number :

Device Description : Ophthalmoscope and Otoscope Diagnostic Set, 2 Pcs AA handle and Zipper Bag

Device Class : 1

Duns Number: 166760392

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

Gilras - 00851158007454 Catalog Number :

Device Description : GRK-6000 Autorefractor/Keratometer

Device Class : 1

Duns Number: 166760392

Premarket Exempt : Yes

Product Code : HKO

Prescription Use : No

Device Count : 1

Gilras - 00851158007478 Catalog Number :

Device Description : Gilras GR-1500 Manual Refractor

Device Class : 1

Duns Number: 166760392

Premarket Exempt : Yes

Product Code : HKN

Prescription Use : No

Device Count : 1

Eli Ezer - 00851158007508 Catalog Number :

Device Description : Eli Ezer Retinoscope EZ-RET-2600/HL

Device Class : 1

Duns Number: 166760392

Premarket Exempt : Yes

Product Code : HKM

Prescription Use : No

Device Count : 1

Eli Ezer - 00851158007515 Catalog Number :

Device Description : Eli Ezer EZ-RET-2600/LL

Device Class : 1

Duns Number: 166760392

Premarket Exempt : Yes

Product Code : HKM

Prescription Use : No

Device Count : 1

Eli Ezer - 00851158007522 Catalog Number :

Device Description : Ezer Diagnosis Wall Unit, 3.5 Led Ophthalmoscope and Otoscope with Dispenser, C Ezer Diagnosis Wall Unit, 3.5 Led Ophthalmoscope and Otoscope with Dispenser, C battery and AC power

Device Class : 1

Duns Number: 166760392

Premarket Exempt : No

Product Code : EPY, HLJ, ERA

Prescription Use : No

Device Count : 1

Eli Ezer - 00851158007539 Catalog Number :

Device Description : Eli Ezer Perimeter EPR-2600

Device Class : 1

Duns Number: 166760392

Premarket Exempt : Yes

Product Code : HPT

Prescription Use : No

Device Count : 1

Eli Ezer - 00851158007546 Catalog Number :

Device Description : Eli Ezer Perimeter EPR-3600

Device Class : 1

Duns Number: 166760392

Premarket Exempt : Yes

Product Code : HPT

Prescription Use : No

Device Count : 1

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