GORE SEAMGUARD Bioabsorbable Staple Line Reinforce CBSG25

GUDID 00733132655496

ETHICON & US SURGICAL 25

W. L. Gore & Associates, Inc.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device ID00733132655496
NIH Device Record Key50d4fec7-571a-48b9-9654-9f08bd96683b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGORE SEAMGUARD Bioabsorbable Staple Line Reinforce
Version Model NumberCBSG25
Catalog NumberCBSG25
Company DUNS967358115
Company NameW. L. Gore & Associates, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132600755 [Package]
Package: [1 Units]
In Commercial Distribution
GS100733132655496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, surgical, polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-13
Device Publish Date2022-12-05

On-Brand Devices [GORE SEAMGUARD Bioabsorbable Staple Line Reinforce]

00733132644766IntuitiveDaVinciXi60Black
00733132644759IntuitiveDaVinciXi60Green
00733132627189OBSGPROX75 ANVIL & CARTRIDGE
00733132627172OBSGPROX55 ANVIL & CARTRIDGE
00733132627165OBSGPROX100 ANVIL & CARTRIDGE
00733132627158OBSGDST80 ANVIL & CARTRIDGE
00733132627141OBSGDST60 ANVIL & CARTRIDGE
00733132627134OBSGDST100 ANVIL & CARTRIDGE
00733132627127BSGUSS60GAC ANVIL & CARTRIDGE
00733132627110BSGUSS60BAC ANVIL & CARTRIDGE
00733132627103BSGUSS45GAC ANVIL & CARTRIDGE
00733132627097BSGUSS45BAC ANVIL & CARTRIDGE
00733132627080BSGTRI60PAC ANVIL & CARTRIDGE
00733132627073BSGTRI60BAC ANVIL & CARTRIDGE
00733132627066BSGTRI45PAC ANVIL & CARTRIDGE
00733132627059BSGTRI45BAC ANVIL & CARTRIDGE
00733132627042BSGEZ45 ANVIL & CARTRIDGE
00733132627035BSGETS60 ANVIL & CARTRIDGE
00733132627028BSGETS45 ANVIL & CARTRIDGE
00733132600342BSGEC60AAC Anvil & Cartridge
00733132600335BSGEC60 Anvil & Cartridge
00733132600328BSGEC45 Anvil & Cartridge
00733132620043COVIDIEN ENDO TRI60 PURPLE
H3731BSGTRI60B36COVIDIEN ENDO TRI60 BLACK
00733132620029COVIDIEN ENDO TRI45 PURPLE
H3731BSGTRI45B39COVIDIEN ENDO TRI45 BLACK
00733132601790ETHICON PROXIMATE 75 1PK
00733132601783ETHICON PROXIMATE 55 1PK
H3731OBSGPROX10036ETHICON PROXIMATE 100 1 PK
00733132601769AUTOSUTURE DST80 1 PK
00733132601752AUTOSUTURE DST60 1 PK
00733132601745AUTOSUTURE DST100 1 PK
00733132600885USS ENDO GIA II 60-4.8MM
00733132600878USS ENDO GIA II 60-2.5MM,3.5MM
00733132600861USS ENDO GIA II 45-4.8MM
00733132600854USS ENDO GIA II 45-2.5MM,3.5MM
00733132600847ETHICON ENDO SURGERY EZ45
00733132600830ETHICON ENDO SURGERY ETS60
H3731BSGETS453ETHICON ENDO SURGERY ETS45
H3731BSGEC60A30ETHICON ENDO SURGERY EC60 FLEX
00733132600809ETHICON ENDO SURGERY EC60
H3731BSGEC453ETHICON ENDO SURGERY EC45
00733132600786ETHICON 33 & US SURGICAL 34
00733132600779US SURGICAL 31
00733132600762US SURGICAL 28 & ETHICON 29
00733132600755ETHICON & US SURGICAL 25
00733132655526ETHICON 33 & US SURGICAL 34
00733132655519US SURGICAL 31
00733132655502US SURGICAL 28 & ETHICON 29
00733132655496ETHICON & US SURGICAL 25

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