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

POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) (KHJ) (6) Mesh, surgical, collagen, large abdominal wall defects (OXK) (2) Mesh, surgical (FTM) (1) Mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed (PAJ) (1)

Premarket Exempt

Clear

Biodesign - 00827002352476 Catalog Number : C-BRG-7X20-US

Device Description : Biodesign Rectopexy Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : PAJ

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002359475 Catalog Number : ENT-TRG-1X2

Device Description : Biodesign Sinonasal Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : KHJ

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002359482 Catalog Number : ENT-TRG-2X3

Device Description : Biodesign Sinonasal Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : KHJ

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002359499 Catalog Number : ENT-TRG-4X7

Device Description : Biodesign Sinonasal Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : KHJ

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002359505 Catalog Number : ENT-TRG-7X10

Device Description : Biodesign Sinonasal Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : KHJ

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002360327 Catalog Number : C-SLH-8H-13X15

Device Description : Biodesign Hernia Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : OXK

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002360334 Catalog Number : C-SLH-8H-20X20

Device Description : Biodesign Hernia Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : OXK

Prescription Use : Yes

Device Count : 1

BIODESIGN - 00827002444515 Catalog Number : ENT-OTO-2.5X2.5

Device Description : Biodesign Otologic Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : KHJ

Prescription Use : Yes

Device Count : 1

BIODESIGN - 00827002444522 Catalog Number : ENT-OTO-5X5

Device Description : Biodesign Otologic Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : KHJ

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002447776 Catalog Number : C-IHM-10X15-B

Device Description : Biodesign Inguinal Hernia Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

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