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) (10)

Premarket Exempt

No Yes

Clear

OmniTrustTM - 00810572002629 Catalog Number : 204-323

Device Description : Nitrile Examination Glove Powder Free Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 300

OmniTrustTM - 00810572002636 Catalog Number : 204-324

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 : 300

OmniTrustTM - 00810572003497 Catalog Number : 201-121

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 - 00810572003503 Catalog Number : 201-122

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 - 00810572003510 Catalog Number : 201-123

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 - 00810572003527 Catalog Number : 201-124

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

OmniTrustTM - 00810572003558 Catalog Number : 201-221

Device Description : Nitrile Examination Glove Powder Free Small

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572003565 Catalog Number : 201-222

Device Description : Nitrile Examination Glove Powder Free Medium

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572003572 Catalog Number : 201-223

Device Description : Nitrile Examination Glove Powder Free Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572003589 Catalog Number : 201-224

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

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