Fresnel Prism & Lens Company

Address:10810 NESBITT AVE S,Bloomington,MN,55437,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

Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (HOY) (6) Set, Lens, Trial, Ophthalmic (HPC) (4)

Premarket Exempt

Yes

Clear

MYI OCCLUSION EYE PATCHES - 00850029104001 Catalog Number :

Device Description : PACKET, JUNIOR, MYI EYE PATCH

Device Class :

Duns Number: 789337987

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 17

MYI OCCLUSION EYE PATCHES - 00850029104018 Catalog Number :

Device Description : PACKET, REGULAR, MYI EYE PATCH

Device Class :

Duns Number: 789337987

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 17

MYI OCCLUSION EYE PATCHES - 00850029104025 Catalog Number :

Device Description : PACKET, REGULAR, MYI EYE PATCH

Device Class :

Duns Number: 789337987

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 10

MYI OCCLUSION EYE PATCHES - 00850029104032 Catalog Number :

Device Description : PACKET, JUNIOR, MYI EYE PATCH

Device Class :

Duns Number: 789337987

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 10

COVERCLUDE OCCLUSION EYE PATCHES - 00850029104049 Catalog Number :

Device Description : PACKET, REGULAR, COVERCLUDE

Device Class :

Duns Number: 789337987

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 10

COVERCLUDE OCCLUSION EYE PATCHES - 00850029104056 Catalog Number :

Device Description : PACKET, JUNIOR, COVERCLUDE

Device Class :

Duns Number: 789337987

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 10

FRESNEL PRISM AND LENS - 00850029104063 Catalog Number : TS-4000

Device Description : SET, LENS, TRIAL, FRESNEL PRISM, 2 - 10 DIOPTER

Device Class : 1

Duns Number: 789337987

Premarket Exempt : Yes

Product Code : HPC

Prescription Use : No

Device Count : 7

FRESNEL PRISM AND LENS - 00850029104070 Catalog Number : TS-5000

Device Description : SET, LENS, TRIAL, FRESNEL PRISM, 12 - 40 DIOPTER

Device Class : 1

Duns Number: 789337987

Premarket Exempt : Yes

Product Code : HPC

Prescription Use : No

Device Count : 7

FRESNEL PRISM AND LENS - 00850029104087 Catalog Number : TS-4000 NH

Device Description : SET, LENS, TRIAL, FRESNEL PRISM, NO HANDLES, 2 - 10 DIOPTER

Device Class : 1

Duns Number: 789337987

Premarket Exempt : Yes

Product Code : HPC

Prescription Use : No

Device Count : 7

FRESNEL PRISM AND LENS - 00850029104094 Catalog Number : TS-5000 NH

Device Description : SET, LENS, TRIAL, FRESNEL PRISM, NO HANDLES, 12 - 40 DIOPTER

Device Class : 1

Duns Number: 789337987

Premarket Exempt : Yes

Product Code : HPC

Prescription Use : No

Device Count : 7

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