CLEAR IMAGE DEVICES LLC

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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) (5) Holder, Radiographic Cassette, Wall-Mounted (IXY) (1)

Premarket Exempt

Yes

Clear

Clear Image Devices - 00811571030002 Catalog Number : 1919

Device Description : Bucky Protector

Device Class : 1

Duns Number: 115272845

Premarket Exempt : Yes

Product Code : IXY

Prescription Use : No

Device Count : 1

Sharn Inc - 00811571030842 Catalog Number : 42593

Device Description : EyeGuardian Sensitive

Device Class : 1

Duns Number: 115272845

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 1

Sharn Inc - 00811571030859 Catalog Number : 49369

Device Description : EyeGuardian

Device Class : 1

Duns Number: 115272845

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 1

Sharn Inc - 00811571030866 Catalog Number : S2020

Device Description : EyeGard

Device Class : 1

Duns Number: 115272845

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 1

Sharn Inc - 00811571030873 Catalog Number : S2020-M

Device Description : EyeGard Sensitive

Device Class : 1

Duns Number: 115272845

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 1

Sharn Inc - 00811571030880 Catalog Number : S2020-P

Device Description : EyeGard Pediatric

Device Class : 1

Duns Number: 115272845

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 1

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