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) (8) Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (DXZ) (2)

Premarket Exempt

Clear

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600816 Catalog Number : 1BSGEC60A

Device Description : ETHICON ENDO SURGERY EC60 FLEX

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600823 Catalog Number : 1BSGETS45

Device Description : ETHICON ENDO SURGERY ETS45

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600830 Catalog Number : 1BSGETS60

Device Description : ETHICON ENDO SURGERY ETS60

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600847 Catalog Number : 1BSGEZ45

Device Description : ETHICON ENDO SURGERY EZ45

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600854 Catalog Number : 1BSGUSS45B

Device Description : USS ENDO GIA II 45-2.5MM,3.5MM

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600861 Catalog Number : 1BSGUSS45G

Device Description : USS ENDO GIA II 45-4.8MM

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600878 Catalog Number : 1BSGUSS60B

Device Description : USS ENDO GIA II 60-2.5MM,3.5MM

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132600885 Catalog Number : 1BSGUSS60G

Device Description : USS ENDO GIA II 60-4.8MM

Device Class :

Duns Number: 967358115

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

GORE ACUSEAL Cardiovascular Patch Vascular - 00733132600892 Catalog Number : 1CVX002

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

GORE ACUSEAL Cardiovascular Patch Vascular - 00733132600908 Catalog Number : 1CVX003

Device Class : 2

Duns Number: 967358115

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

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