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) (9) Dressing, wound, collagen (KGN) (1)

Premarket Exempt

Clear

OASIS - 00827002576100 Catalog Number : 8213-3000-14

Device Description : OASIS Burn Matrix

Device Class : U

Duns Number: 945385862

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002583962 Catalog Number : C-SLRA-60

Device Description : Biodesign Staple Line Reinforcement

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002583979 Catalog Number : C-SLRA-45

Device Description : Biodesign Staple Line Reinforcement

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Fortify - 00827002590595 Catalog Number : FTRG-1X10

Device Description : Fortify TRG Tissue Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Fortify - 00827002590601 Catalog Number : FTRG-4X7

Device Description : Fortify TRG Tissue Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Fortify - 00827002590618 Catalog Number : FTRG-7X10

Device Description : Fortify TRG Tissue Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Fortify - 00827002590625 Catalog Number : FTRG-7X20

Device Description : Fortify TRG Tissue Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Fortify - 00827002590632 Catalog Number : FTRG-1X10-S

Device Description : Fortify TRG Tissue Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Fortify - 00827002590649 Catalog Number : FTRG-4X7-S

Device Description : Fortify TRG Tissue Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Fortify - 00827002590656 Catalog Number : FTRG-7X10-S

Device Description : Fortify TRG Tissue Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

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