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

Mesh, surgical, polymeric (FTL) (6) Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (DXZ) (4)

Premarket Exempt

Clear

GORE-TEX Cardiovascular Patch - 00733132600717 Catalog Number : 1803003004

Device Description : STP 3.0 CM X 3.0 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 - 00733132600724 Catalog Number : 1803006004

Device Description : STP 3.0 CM X 6.0 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 - 00733132600731 Catalog Number : 1905007508

Device Description : STP 5.0 CM X 7.5 CM X 0.8 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

GORE-TEX Cardiovascular Patch - 00733132600748 Catalog Number : 1910015008

Device Description : STP 10.0 CM X 15.0 CM X 0.8 MM

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600755 Catalog Number : 1BSGC25

Device Description : ETHICON & US SURGICAL 25

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600762 Catalog Number : 1BSGC2829

Device Description : US SURGICAL 28 & ETHICON 29

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600779 Catalog Number : 1BSGC31

Device Description : US SURGICAL 31

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600786 Catalog Number : 1BSGC3334

Device Description : ETHICON 33 & US SURGICAL 34

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600793 Catalog Number : 1BSGEC45

Device Description : ETHICON ENDO SURGERY EC45

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600809 Catalog Number : 1BSGEC60

Device Description : ETHICON ENDO SURGERY EC60

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

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