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

Tape and bandage, adhesive (KGX) (7) Dressing, wound, occlusive (NAD) (2) Gauze / sponge,nonresorbable for external use (NAB) (1)

Premarket Exempt

No Yes

Clear

OmniTrustTM - 00810572006474 Catalog Number : 9084-52

Device Description : Adhesive Bandages, fabric, fingertip

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572006481 Catalog Number : 9084-71

Device Description : Adhesive Bandages, fabric, spot

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572006498 Catalog Number : 9084-61

Device Description : Adhesive Bandages, fabric, Patch

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 50

OmniTrustTM - 00810572006504 Catalog Number : 9089-21

Device Description : Adhesive Bandages, clear, 3/4x3

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572006511 Catalog Number : 9089-22

Device Description : Adhesive Bandages, clear, 1x3

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572006528 Catalog Number : 9086-22

Device Description : Adhesive Bandages, fabric-Blue Metal Detectable, 1x3

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572006542 Catalog Number : 9091-21

Device Description : Non-Adherenet Dressing, Sterile, 2x3

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572006559 Catalog Number : 9091-31

Device Description : Non-Adherenet Dressing, Sterile, 3x4

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572006566 Catalog Number : 9101-41

Device Description : Drain Sponge, Sterile, 4x4, 6 ply

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 25

OmniTrustTM - 00810572006573 Catalog Number : 9085-21

Device Description : Adhesive Bandages, plastic, 3/4x3

Device Class :

Duns Number: 079434709

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 100

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