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, collagen, staple line reinforcement (OXE) (4) DURA SUBSTITUTE (GXQ) (3) Mesh, surgical (FTM) (2) Mesh, surgical, collagen, large abdominal wall defects (OXK) (1)

Premarket Exempt

Clear

Biodesign - 00827002236530 Catalog Number : EFPD-0.7

Device Description : Biodesign Enterocutaneous Fistula Plug

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002236547 Catalog Number : EFPD-0.4

Device Description : Biodesign Enterocutaneous Fistula Plug

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002236622 Catalog Number : C-SLRA-TN45

Device Description : Biodesign Staple Line Reinforcement

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : OXE

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002237643 Catalog Number : C-SLH-8H-10X10

Device Description : Biodesign Hernia Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : OXK

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002248274 Catalog Number : C-SLRA-TN60

Device Description : Biodesign Staple Line Reinforcement

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : OXE

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002250062 Catalog Number : C-SLRA-TRI45

Device Description : Biodesign Staple Line Reinforcement

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : OXE

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002250079 Catalog Number : C-SLRA-TRI60

Device Description : Biodesign Staple Line Reinforcement

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : OXE

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002310902 Catalog Number : C-DUR-4X7

Device Description : Biodesign Dural Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : GXQ

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002310919 Catalog Number : C-DUR-7X10

Device Description : Biodesign Dural Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : GXQ

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002310926 Catalog Number : C-DUR-7X20

Device Description : Biodesign Dural Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : GXQ

Prescription Use : Yes

Device Count : 1

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