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

Gauze / sponge,nonresorbable for external use (NAB) (10)

Premarket Exempt

No Yes

Clear

OmniTrustTM - 00810572006078 Catalog Number : 9012-44

Device Description : Gauze Sponge, Non-Sterile, 4x4, 12 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572006085 Catalog Number : 9012-23

Device Description : Gauze Sponge, Non-Sterile, 2x2, 8 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572006092 Catalog Number : 9012-33

Device Description : Gauze Sponge, Non-Sterile, 3x3, 8 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572006108 Catalog Number : 9012-43

Device Description : Gauze Sponge, Non-Sterile, 4x4, 8 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572006115 Catalog Number : 9012-45

Device Description : Gauze Sponge, Non-Sterile, 4x4, 16 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572006122 Catalog Number : 9011-23

Device Description : Gauze Sponge, Sterile, 2x2, 8 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 50

OmniTrustTM - 00810572006139 Catalog Number : 9011-43

Device Description : Gauze Sponge, Sterile, 4x4, 8 ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 25

OmniTrustTM - 00810572006146 Catalog Number : 9011-34

Device Description : Gauze Sponge, Sterile, 3x3, 12 ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 40

OmniTrustTM - 00810572006153 Catalog Number : 9011-44

Device Description : Gauze Sponge, Sterile, 4x4, 12 ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 25

OmniTrustTM - 00810572006160 Catalog Number : 9021-24

Device Description : Gauze Pads, Sterile, 2x2, 12 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 100

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