COOK BIOTECH INCORPORATED

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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

CUFF, NERVE (JXI) (6) Dressing, wound, collagen (KGN) (4)

Premarket Exempt

Clear

AxoGuard - 00827002351301 Catalog Number : AGX215

Device Description : AxoGuard Nerve Connector

Device Class :

Duns Number: 945385862

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

AxoGuard - 00827002351318 Catalog Number : AGX315

Device Description : AxoGuard Nerve Connector

Device Class :

Duns Number: 945385862

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

AxoGuard - 00827002351325 Catalog Number : AGX415

Device Description : AxoGuard Nerve Connector

Device Class :

Duns Number: 945385862

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

AxoGuard - 00827002351332 Catalog Number : AGX515

Device Description : AxoGuard Nerve Connector

Device Class :

Duns Number: 945385862

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

AxoGuard - 00827002351349 Catalog Number : AGX615

Device Description : AxoGuard Nerve Connector

Device Class :

Duns Number: 945385862

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

AxoGuard - 00827002351356 Catalog Number : AGX715

Device Description : AxoGuard Nerve Connector

Device Class :

Duns Number: 945385862

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

OASIS - 00827002352421 Catalog Number : 8213-0000-16

Device Description : OASIS Ultra Tri-Layer Matrix

Device Class : U

Duns Number: 945385862

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

OASIS - 00827002352438 Catalog Number : 8213-0000-17

Device Description : OASIS Ultra Tri-Layer Matrix

Device Class : U

Duns Number: 945385862

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

OASIS - 00827002352445 Catalog Number : 8213-0000-18

Device Description : OASIS Ultra Tri-Layer Matrix

Device Class : U

Duns Number: 945385862

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

OASIS - 00827002352452 Catalog Number : 8213-0000-19

Device Description : OASIS Ultra Tri-Layer Matrix

Device Class : U

Duns Number: 945385862

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

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