W. L. Gore & Associates, Inc.

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

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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) (6) PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER (DSY) (4)

Premarket Exempt

Clear

GORE Hybrid Vascular Graft-CBAS - 00733132600038 Catalog Number : 0650HYB0605A

Device Description : HYBRID VASCULAR GRAFT 6-6MM US

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

GORE Hybrid Vascular Graft-CBAS - 00733132600052 Catalog Number : 0650HYB0705A

Device Description : HYBRID VASCULAR GRAFT 6-7MM US

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

GORE Hybrid Vascular Graft-CBAS - 00733132600076 Catalog Number : 0650HYB0805A

Device Description : HYBRID VASCULAR GRAFT 6-8MM US

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

GORE Hybrid Vascular Graft-CBAS - 00733132600090 Catalog Number : 0650HYB0905A

Device Description : HYBRID VASCULAR GRAFT 6-9MM US

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

GORE-TEX Suture - 00733132600106 Catalog Number : 0N05A

Device Description : CV-0 SUTURE 36" THX-26 SA 1DZ

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 12

GORE-TEX Suture - 00733132600113 Catalog Number : 0N05B

Device Description : CV-0 SUTURE 36" THX-26 SA 3DZ

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 36

GORE-TEX Suture - 00733132600120 Catalog Number : 0N07A

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

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 12

GORE-TEX Suture - 00733132600137 Catalog Number : 0N07B

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

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 36

GORE-TEX Suture - 00733132600144 Catalog Number : 0N08A

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

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 12

GORE-TEX Suture - 00733132600151 Catalog Number : 0N08B

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

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : GAW

Prescription Use : Yes

Device Count : 36

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