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

Mesh, surgical (FTM) (7) Dressing, wound, collagen (KGN) (2) Mesh, surgical, collagen, staple line reinforcement (OXE) (1)

Premarket Exempt

Clear

Biodesign - 00827002125797 Catalog Number : C-SLH-4S-7X20

Device Description : Biodesign 4-Layer Tissue Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002125803 Catalog Number : C-SLH-4S-7X10

Device Description : Biodesign 4-Layer Tissue Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002125810 Catalog Number : C-SLH-1S-7X10

Device Description : Biodesign 1-Layer Tissue Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002128477 Catalog Number : SLH-1S-7X10

Device Description : Biodesign 1-Layer Tissue Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002131811 Catalog Number : C-SLH-4S-4X7

Device Description : Biodesign 4-Layer Tissue Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002132214 Catalog Number : C-SLH-1S-2X3

Device Description : Biodesign 1-Layer Tissue Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002135444 Catalog Number : C-SLH-4S-1X10

Device Description : Biodesign 4-Layer Tissue Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

OASIS - 00827002231191 Catalog Number : 8213-0000-13

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 - 00827002231207 Catalog Number : 8213-0000-14

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

Biodesign - 00827002232013 Catalog Number : C-SLRA-SC60

Device Description : Biodesign Staple Line Reinforcement

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : OXE

Prescription Use : Yes

Device Count : 1

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