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

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs (OPJ) (4) Polymer Patient Examination Glove (LZA) (4) Gauze / sponge,nonresorbable for external use (NAB) (2)

Premarket Exempt

No Yes

Clear

OmniTrustTM - 00810572003831 Catalog Number : 216-21

Device Description : Nitrile Examination Glove Powder Free Small

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : OPJ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572003848 Catalog Number : 216-22

Device Description : Nitrile Examination Glove Powder Free Medium

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : OPJ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572003855 Catalog Number : 216-23

Device Description : Nitrile Examination Glove Powder Free Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : OPJ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572003862 Catalog Number : 216-24

Device Description : Nitrile Examination Glove Powder Free X-Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : OPJ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572004197 Catalog Number : 215-41

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 - 00810572004203 Catalog Number : 215-42

Device Description : Nitrile Examination Gloves Powder Free Medium

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572004210 Catalog Number : 215-43

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 - 00810572004227 Catalog Number : 215-44

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

OmniTrustTM - 00810572006054 Catalog Number : 9012-24

Device Description : Gauze Sponge, Non-Sterile, 2x2, 12 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572006061 Catalog Number : 9012-34

Device Description : Gauze Sponge, Non-Sterile, 3x3, 12 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

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