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, polymeric (FTL) (6) Mesh, surgical (FTM) (3) Mesh, surgical, collagen, large abdominal wall defects (OXK) (1)

Premarket Exempt

Clear

Zenapro - 10827002237701 Catalog Number : C-HYB-20X30

Device Description : Zenapro Hybrid Hernia Repair Device

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

Zenapro - 10827002237718 Catalog Number : C-HYB-15X22

Device Description : Zenapro Hybrid Hernia Repair Device

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

Zenapro - 10827002237725 Catalog Number : C-HYB-15D

Device Description : Zenapro Hybrid Hernia Repair Device

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

Biodesign - 10827002239460 Catalog Number : C-BIG-10X40

Device Description : Biodesign Incision Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : OXK

Prescription Use : Yes

Device Count : 1

Biodesign - 10827002311418 Catalog Number : C-IHM-10X15

Device Description : Biodesign Inguinal Hernia Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Biodesign - 10827002314518 Catalog Number : C-IHM-6X13-P

Device Description : Biodesign Inguinal Hernia Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Biodesign - 10827002314525 Catalog Number : C-IHM-8X15-P

Device Description : Biodesign Inguinal Hernia Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Zenapro - 10827002351148 Catalog Number : C-HYB-30X30

Device Description : Zenapro Hybrid Hernia Repair Device

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

Zenapro - 10827002354767 Catalog Number : C-HYB-10D

Device Description : Zenapro Hybrid Hernia Repair Device

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

Zenapro - 10827002354774 Catalog Number : C-HYB-10X15

Device Description : Zenapro Hybrid Hernia Repair Device

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

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