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

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (DXZ) (8) Mesh, Surgical, Polymeric (FTL) (2)

Premarket Exempt

Clear

GORE-TEX Soft Tissue Patch - 00733132600618 Catalog Number : 1420030010

Device Description : STP 20.0 CM X 30.0 CM X 1.0 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE-TEX Soft Tissue Patch - 00733132600625 Catalog Number : 142603401A

Device Description : STP 26.0 CM X 34.0 CM X 1.0 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE-TEX Cardiovascular Patch - 00733132600632 Catalog Number : 1702503806

Device Description : STP 2.5 CM X 3.8 CM X .6 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

GORE-TEX Cardiovascular Patch - 00733132600649 Catalog Number : 1702515006

Device Description : STP 2.5 CM X 15.0 CM X .6 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

GORE-TEX Cardiovascular Patch - 00733132600656 Catalog Number : 1705007506

Device Description : STP 5.0 CM X 7.5 CM X .6 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

GORE-TEX Cardiovascular Patch - 00733132600663 Catalog Number : 1705015006

Device Description : STP 5.0 CM X 15.0 CM X .6 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

GORE-TEX Cardiovascular Patch - 00733132600670 Catalog Number : 1710015006

Device Description : STP 10.0 CM X 15.0 CM X .6 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

GORE-TEX Cardiovascular Patch - 00733132600687 Catalog Number : 1800610004

Device Description : STP .6 CM X 10.0 CM X .4 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

GORE-TEX Cardiovascular Patch - 00733132600694 Catalog Number : 1802009004

Device Description : STP 2.0 CM X 9.0 CM X .4 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

GORE-TEX Cardiovascular Patch - 00733132600700 Catalog Number : 1802014004

Device Description : STP 2.0 CM X 14.0 CM X .4 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

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