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

Dressing, wound, collagen (KGN) (3) CATHETER, IRRIGATION (GBX) (2) Mesh, surgical (FTM) (2) POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) (KHJ) (2) Mesh, surgical, collagen, large abdominal wall defects (OXK) (1)

Premarket Exempt

Clear

Biodesign - 00827002447783 Catalog Number : C-IHM-6X13-P-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

Biodesign - 00827002447790 Catalog Number : C-IHM-8X15-P-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

Biodesign - 00827002448391 Catalog Number : ENT-OTO-0.6-0.9

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 - 00827002448407 Catalog Number : ENT-OTO-0.4-0.6

Device Description : Biodesign Otologic Repair Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : KHJ

Prescription Use : Yes

Device Count : 1

HaloShield - 00827002462892 Catalog Number : C-SHIELD-1.0

Device Description : HaloShield Nipple Protector

Device Class : 1

Duns Number: 945385862

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

HaloShield - 00827002462908 Catalog Number : C-SHIELD-2.0

Device Description : HaloShield Nipple Protector

Device Class : 1

Duns Number: 945385862

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Biodesign - 00827002466005 Catalog Number : C-SLH-8H-13X22

Device Description : Biodesign Hernia Graft

Device Class : 2

Duns Number: 945385862

Premarket Exempt : No

Product Code : OXK

Prescription Use : Yes

Device Count : 1

OASIS - 00827002466227 Catalog Number : 8213-1000-33

Device Description : OASIS Wound Matrix

Device Class : U

Duns Number: 945385862

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

OASIS - 00827002466234 Catalog Number : 8213-2000-33

Device Description : OASIS Wound Matrix

Device Class : U

Duns Number: 945385862

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

OASIS - 00827002466265 Catalog Number : 8213-1000-37

Device Description : OASIS Wound Matrix

Device Class : U

Duns Number: 945385862

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

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