FDA.report

GORE® TAG® Thoracic Branch Endoprosthesis

Primary DI
00733132667017
Brand
GORE® TAG® Thoracic Branch Endoprosthesis
Company
W. L. Gore & Associates, Inc.
Model
TAC124010A
Catalog number
TAC124010A
Device description
TAG TBE THORACIC AORTIC BRANCH TAG TBE AC 12MMX40MMX10CM
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Product Code Classifications

CodeDeviceSpecialtyClass
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00733132667017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132667017007331326670177331326670170733132667017

GMDN Terms

TermDefinition
Aortic arch endovascular stent-graftA non-bioabsorbable tubular device intended for endovascular implantation, in a modular configuration, to repair lesions of the aortic arch and descending thoracic aorta. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft). It includes a docking portal(s) for attachment of an ancillary endovascular stent-graft(s) [not included] to occupy and allow flow to an aortic arch branch vessel(s). It is percutaneously inserted via the femoral artery to the site of implantation and expanded in situ; disposable devices associated with implantation may be included.

Contacts

PhoneEmail
+1(800)528-8763mpdcustomercare@wlgore.com

Regulatory Flags

DUNS number
967358115
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00733132666980GORE® TAG® Thoracic Branch EndoprosthesisTAC123110ATAC123110A2026-05-26
00733132666997GORE® TAG® Thoracic Branch EndoprosthesisTAC123410ATAC123410A2026-05-26
00733132667000GORE® TAG® Thoracic Branch EndoprosthesisTAC123710ATAC123710A2026-05-26
00733132667024GORE® TAG® Thoracic Branch EndoprosthesisTAC124510ATAC124510A2026-05-26
00733132663682GORE® VIABAHN® FORTEGRA Venous StentVNS100502A VNS100502A 2026-01-08
00733132663699GORE® VIABAHN® FORTEGRA Venous StentVNS240702AVNS240702A2026-01-08
00733132663705GORE® VIABAHN® FORTEGRA Venous StentVNS281502AVNS281502A2026-01-08
00733132663712GORE® VIABAHN® FORTEGRA Venous StentVNS281002AVNS281002A2026-01-08
00733132663729GORE® VIABAHN® FORTEGRA Venous StentVNS280702AVNS280702A2026-01-08
00733132663736GORE® VIABAHN® FORTEGRA Venous StentVNS280502AVNS280502A2026-01-08
00733132663743GORE® VIABAHN® FORTEGRA Venous StentVNS241502AVNS241502A2026-01-08
00733132663750GORE® VIABAHN® FORTEGRA Venous StentVNS241002AVNS241002A2026-01-08
00733132663767GORE® VIABAHN® FORTEGRA Venous StentVNS240502AVNS240502A2026-01-08
00733132663774GORE® VIABAHN® FORTEGRA Venous StentVNS201502AVNS201502A2026-01-08
00733132663781GORE® VIABAHN® FORTEGRA Venous StentVNS201002AVNS201002A2026-01-08
00733132663798GORE® VIABAHN® FORTEGRA Venous StentVNS200702AVNS200702A2026-01-08
00733132663804GORE® VIABAHN® FORTEGRA Venous StentVNS200502AVNS200502A2026-01-08
00733132663811GORE® VIABAHN® FORTEGRA Venous StentVNS181502AVNS181502A2026-01-08
00733132663828GORE® VIABAHN® FORTEGRA Venous StentVNS181002AVNS181002A2026-01-08
00733132663835GORE® VIABAHN® FORTEGRA Venous StentVNS180702AVNS180702A2026-01-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00733132666980GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132666997GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132667000GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132667024GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
10827002603407COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603414COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603421COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603438COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603445COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603452COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603469COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603476COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00733132661664GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661671GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661688GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661695GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
10827002601595Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601656Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601717Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601748Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601779Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601809Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601830Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601861Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601892Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601922Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601953Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601984Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002602011Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002602042Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18