OMNI INTERNATIONAL CORP.

Address:35 Constitution Dr Ste 1D,BEDFORD,NH,03110,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) (1) Tape and bandage, adhesive (KGX) (1)

Premarket Exempt

No Yes

Clear

OmniTrustTM - 00810572006580 Catalog Number : 9085-22

Device Description : Adhesive Bandages, plastic, 1x3

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 100

OmniTrustTM - 50810572000095 Catalog Number : 50325-19

Device Description : Face Shield

Device Class : 1

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 480

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