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

Polymer patient examination glove (LZA) (8) First Aid Kit with drug (LRR) (2)

Premarket Exempt

No Yes

Clear

OmniTrustTM - 00810572001622 Catalog Number : 203-24

Device Description : Nitrile Examination Glove Powder Free X-Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572001639 Catalog Number : 203-25

Device Description : Nitrile Examination Glove Powder Free XX-Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572002131 Catalog Number : 213-41

Device Description : Nitrile Examination Glove Powder Free Small

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572002148 Catalog Number : 213-42

Device Description : Nitrile Examination Glove Powder Free Medium

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572002155 Catalog Number : 213-43

Device Description : Nitrile Examination Glove Powder Free Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572002162 Catalog Number : 213-44

Device Description : Nitrile Examination Glove Powder Free X-Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

OmniSafeTM - 00810572002186 Catalog Number : FAK-0010

Device Description : First Aid Kit

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : LRR

Prescription Use : No

Device Count : 1

OmniSafeTM - 00810572002193 Catalog Number : FAK-0025

Device Description : First Aid Kit

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : LRR

Prescription Use : No

Device Count : 1

OmniTrustTM - 00810572002605 Catalog Number : 204-321

Device Description : Nitrile Examination Glove Powder Free Small

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 300

OmniTrustTM - 00810572002612 Catalog Number : 204-322

Device Description : Nitrile Examination Glove Powder Free Medium

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 300

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