W. L. Gore & Associates, Inc.

Address:1505 NORTH FOURTH ST.,FLAGSTAFF,AZ,86004,US

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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

SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE (GAW) (9) Mesh, Surgical, Polymeric (FTL) (1)

Premarket Exempt

Clear

GORE-TEX Suture - 00733132600168 Catalog Number : 0N09A

Device Description : CV-0 SUTURE 36" TFX-25 SA 1DZ

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 12

GORE-TEX Suture - 00733132600175 Catalog Number : 0N09B

Device Description : CV-0 SUTURE 36" TFX-25 SA 3DZ

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 36

GORE-TEX Suture - 00733132600182 Catalog Number : 0N13A

Device Description : CV-0 SUTURE 36" THX-25 SA 1DZ

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 12

GORE-TEX Suture - 00733132600199 Catalog Number : 0N13B

Device Description : CV-0 SUTURE 36" THX-25 SA 3DZ

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 36

GORE-TEX Suture - 00733132600229 Catalog Number : 0U01A

Device Description : CV-0 SUTURE 48" TH-50 SA 1DZ

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 12

GORE-TEX Suture - 00733132600236 Catalog Number : 0U01B

Device Description : CV-0 SUTURE 48" TH-50 SA 3DZ

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 36

GORE-TEX Suture - 00733132600243 Catalog Number : 0U03A

Device Description : CV-0 SUTURE 48" TLX-25 SA 1DZ

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 12

GORE-TEX Suture - 00733132600267 Catalog Number : 0U06A

Device Description : CV-0 SUTURE 48" THX-26 DA 1DZ

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 12

GORE-TEX Suture - 00733132600274 Catalog Number : 0U06B

Device Description : CV-0 SUTURE 48" THX-26 DA 3DZ

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 36

GORE-TEX Soft Tissue Patch - 00733132600489 Catalog Number : 1305010020

Device Description : STP 5.0 CM X 10.0 CM X 2.0 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

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