GORE VIABAHN Endoprosthesis with Heparin

Primary DI
00733132614912
Brand
GORE VIABAHN Endoprosthesis with Heparin
Company
W. L. Gore & Associates, Inc.
Model
VBH070202
Catalog number
VBH070202
Device description
VIABAHN SX ENDO HEPARIN 35 7mmX2.5cm 8Fr120cmCath
Published
2017-03-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIPStent, Superficial Femoral Artery
PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3
PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040037004
P130006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040037004VIABAHN ENDOPROSTHESISW. L. Gore & Associates, Inc.2005-06-14NIP
P130006000GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACEW. L. Gore & Associates, Inc.2013-12-05PFV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132614912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132614912007331326149127331326149120733132614912

GMDN Terms#

Term, Definition table
TermDefinition
Multiple peripheral artery stent, bare-metalA sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.5Centimeter
Lumen/Inner Diameter7Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005288763mpdcustomercare@wlgore.com

Regulatory Flags#

DUNS number
967358115
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733132666980GORE® TAG® Thoracic Branch EndoprosthesisTAC123110ATAC123110A2026-05-26
00733132666997GORE® TAG® Thoracic Branch EndoprosthesisTAC123410ATAC123410A2026-05-26
00733132667000GORE® TAG® Thoracic Branch EndoprosthesisTAC123710ATAC123710A2026-05-26
00733132667017GORE® TAG® Thoracic Branch EndoprosthesisTAC124010ATAC124010A2026-05-26
00733132667024GORE® TAG® Thoracic Branch EndoprosthesisTAC124510ATAC124510A2026-05-26
00733132607211GORE INTERING Vascular GraftIRST06005005LIRST06005005L2017-02-13
00733132610457GORE-TEX Vascular GraftR20030030R200300302017-01-10
00733132612505GORE-TEX STRETCH Vascular Graft Pediatric ShuntST03005AST03005A2017-01-10
00733132612512GORE-TEX Vascular Graft Pediatric ShuntST03010AST03010A2017-01-10
00733132612536GORE-TEX Vascular Graft Pediatric ShuntST04010AST04010A2017-01-10
00733132612543GORE-TEX Vascular Graft Pediatric ShuntST04015AST04015A2017-01-10
00733132612567GORE-TEX Vascular GraftST05010AST05010A2017-01-10
00733132612574GORE-TEX Vascular GraftST05015AST05015A2017-01-10
00733132612604GORE-TEX Vascular GraftST06015AST06015A2017-01-10
00733132612802GORE-TEX Vascular GraftST35005AST35005A2017-01-10
00733132612819GORE-TEX Vascular GraftST35010AST35010A2017-01-10
00733132612826GORE-TEX Vascular GraftST35015AST35015A2017-01-10
00733132615131GORE VIABAHN Endoprosthesis with HeparinVBH101002VBH1010022015-11-17
00733132615179GORE VIABAHN Endoprosthesis with HeparinVBH111002VBH1110022015-11-17
00733132615858GORE-TEX Vascular Graft Pediatric ShuntVT03010LAVT03010LA2017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20705032082331S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082362S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082379S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082386S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082409S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082423S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082447S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082485S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082508S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082553S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082584S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082614S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082652S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
08717648225888SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225901SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225925SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225949SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225963SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225987SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226007SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226021SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226045SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226069SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226083SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226106SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226120SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226144SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226168SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226182SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226205SUPERAABBOTT VASCULAR INC.NIP2018-04-13