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) (8) DRESSING, COMPRESSION (MHW) (1) PAD, EYE (HMP) (1)

Premarket Exempt

No Yes

Clear

OmniTrustTM - 00810572006177 Catalog Number : 9021-34

Device Description : Gauze Pads, Sterile, 3x3, 12 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572006184 Catalog Number : 9021-44

Device Description : Gauze Pads, Sterile, 4x4 12 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572006191 Catalog Number : 9032-21

Device Description : Non-Woven Sponge, Non-Sterile, 2x2, 4 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572006207 Catalog Number : 9032-31

Device Description : Non-Woven Sponge, Non-Sterile, 3x3, 4 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572006214 Catalog Number : 9032-41

Device Description : Non-Woven Sponge, Non-Sterile, 4x4, 4 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572006221 Catalog Number : 9031-21

Device Description : Non-Woven Sponge, Sterile, 2x2, 4 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 50

OmniTrustTM - 00810572006238 Catalog Number : 9031-31

Device Description : Non-Woven Sponge, Sterile, 3x3, 4 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 50

OmniTrustTM - 00810572006245 Catalog Number : 9031-41

Device Description : Non-Woven Sponge, Sterile, 4x4, 4 Ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 50

OmniTrustTM - 00810572006252 Catalog Number : 9051-21

Device Description : Eye Pad, Sterile

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : HMP

Prescription Use : No

Device Count : 50

OmniTrustTM - 00810572006269 Catalog Number : 9062-23

Device Description : Conforming Elastic Bandage, Non-Sterile 2x75

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : MHW

Prescription Use : No

Device Count : 12

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