GORE SEAMGUARD Bioabsorbable Staple Line Reinforce CBSG3334

GUDID 00733132655526

ETHICON 33 & US SURGICAL 34

W. L. Gore & Associates, Inc.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: 00733132655526
• NIH Device Record Key: c9a98931-b21c-4ac9-ab69-075ed37cb17f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE SEAMGUARD Bioabsorbable Staple Line Reinforce
• Version Model Number: CBSG3334
• Catalog Number: CBSG3334
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132600786 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00733132655526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053200

FDA Product Code

• FTL: Mesh, surgical, polymeric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-13
• Device Publish Date: 2022-12-05

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

• 00733132644766: IntuitiveDaVinciXi60Black
• 00733132644759: IntuitiveDaVinciXi60Green
• 00733132627189: OBSGPROX75 ANVIL & CARTRIDGE
• 00733132627172: OBSGPROX55 ANVIL & CARTRIDGE
• 00733132627165: OBSGPROX100 ANVIL & CARTRIDGE
• 00733132627158: OBSGDST80 ANVIL & CARTRIDGE
• 00733132627141: OBSGDST60 ANVIL & CARTRIDGE
• 00733132627134: OBSGDST100 ANVIL & CARTRIDGE
• 00733132627127: BSGUSS60GAC ANVIL & CARTRIDGE
• 00733132627110: BSGUSS60BAC ANVIL & CARTRIDGE
• 00733132627103: BSGUSS45GAC ANVIL & CARTRIDGE
• 00733132627097: BSGUSS45BAC ANVIL & CARTRIDGE
• 00733132627080: BSGTRI60PAC ANVIL & CARTRIDGE
• 00733132627073: BSGTRI60BAC ANVIL & CARTRIDGE
• 00733132627066: BSGTRI45PAC ANVIL & CARTRIDGE
• 00733132627059: BSGTRI45BAC ANVIL & CARTRIDGE
• 00733132627042: BSGEZ45 ANVIL & CARTRIDGE
• 00733132627035: BSGETS60 ANVIL & CARTRIDGE
• 00733132627028: BSGETS45 ANVIL & CARTRIDGE
• 00733132600342: BSGEC60AAC Anvil & Cartridge
• 00733132600335: BSGEC60 Anvil & Cartridge
• 00733132600328: BSGEC45 Anvil & Cartridge
• 00733132620043: COVIDIEN ENDO TRI60 PURPLE
• H3731BSGTRI60B36: COVIDIEN ENDO TRI60 BLACK
• 00733132620029: COVIDIEN ENDO TRI45 PURPLE
• H3731BSGTRI45B39: COVIDIEN ENDO TRI45 BLACK
• 00733132601790: ETHICON PROXIMATE 75 1PK
• 00733132601783: ETHICON PROXIMATE 55 1PK
• H3731OBSGPROX10036: ETHICON PROXIMATE 100 1 PK
• 00733132601769: AUTOSUTURE DST80 1 PK
• 00733132601752: AUTOSUTURE DST60 1 PK
• 00733132601745: AUTOSUTURE DST100 1 PK
• 00733132600885: USS ENDO GIA II 60-4.8MM
• 00733132600878: USS ENDO GIA II 60-2.5MM,3.5MM
• 00733132600861: USS ENDO GIA II 45-4.8MM
• 00733132600854: USS ENDO GIA II 45-2.5MM,3.5MM
• 00733132600847: ETHICON ENDO SURGERY EZ45
• 00733132600830: ETHICON ENDO SURGERY ETS60
• H3731BSGETS453: ETHICON ENDO SURGERY ETS45
• H3731BSGEC60A30: ETHICON ENDO SURGERY EC60 FLEX
• 00733132600809: ETHICON ENDO SURGERY EC60
• H3731BSGEC453: ETHICON ENDO SURGERY EC45
• 00733132600786: ETHICON 33 & US SURGICAL 34
• 00733132600779: US SURGICAL 31
• 00733132600762: US SURGICAL 28 & ETHICON 29
• 00733132600755: ETHICON & US SURGICAL 25
• 00733132655526: ETHICON 33 & US SURGICAL 34
• 00733132655519: US SURGICAL 31
• 00733132655502: US SURGICAL 28 & ETHICON 29
• 00733132655496: ETHICON & US SURGICAL 25