FDA.reportPublic FDA data

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce

Primary DI
00733132644780
Brand
GORE SEAMGUARD Bioabsorbable Staple Line Reinforce
Company
W. L. Gore & Associates, Inc.
Model
20055721
Catalog number
20055721
Device description
IntuitiveDaVinciXi60Black
Published
2018-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXCMesh, Surgical, Absorbable, Staple Line Reinforcement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXCMesh, Surgical, Absorbable, Staple Line ReinforcementGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181940000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181940000GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc.2018-08-17OXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132644735PackageGS11In Commercial Distribution
00733132644766PackageGS112In Commercial Distribution
00733132644780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132644735007331326447357331326447350733132644735
00733132644766007331326447667331326447660733132644766
00733132644780007331326447807331326447800733132644780

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableAn implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polyglycolide] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Contacts#

Phone, Email table
PhoneEmail
1(800)528-8763mpdcustomercare@wlgore.com

Regulatory Flags#

DUNS number
967358115
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733132658855GORE® DrySeal Flex Introducer SheathGDSF1033GDSF10332024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathGDSF1045GDSF10452024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathGDSF1065GDSF10652024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathGDSF1133GDSF11332024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathGDSF1233GDSF12332024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathGDSF1245GDSF12452024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathGDSF1265GDSF12652024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathGDSF1433GDSF14332024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathGDSF1465GDSF14652024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathGDSF1533GDSF15332024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathGDSF1633GDSF16332024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathGDSF1665GDSF16652024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathGDSF1833GDSF18332024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathGDSF1865GDSF18652024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathGDSF2033GDSF20332024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathGDSF2065GDSF20652024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathGDSF2233GDSF22332024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathGDSF2265GDSF22652024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathGDSF2433GDSF24332024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathGDSF2465GDSF24652024-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04548366322450NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322467NEOVEILGUNZE LIMITEDOXC2025-04-21
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04548366322542NEOVEILGUNZE LIMITEDOXC2025-04-21
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04548366830313NEOVEILGUNZE LIMITEDOXC2025-04-21
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04973077713776NEOVEILGUNZE LIMITEDOXC2023-03-27
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10705036023296ECHLEONETHICON ENDO-SURGERY, LLCOXC2021-11-17
20705036023293ECHLEONETHICON ENDO-SURGERY, LLCOXC2021-11-17
04547301462534NEOVEILGUNZE LIMITEDOXC2021-01-06
04547301462558NEOVEILGUNZE LIMITEDOXC2021-01-06
04548366322481NEOVEILGUNZE LIMITEDOXC2019-11-04
00733132644568GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644575GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644582GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644599GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644605GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644612GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644629GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644636GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644643GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644650GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28