GORE VIABAHN Endoprosthesis with Heparin

Primary DI
00733132615179
Brand
GORE VIABAHN Endoprosthesis with Heparin
Company
W. L. Gore & Associates, Inc.
Model
VBH111002
Catalog number
VBH111002
Device description
VIABAHN SX ENDO HEPARIN 35 11mmX10cm 11Fr 120cmCath
Published
2015-11-17
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
P040037013
P130006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040037013VIABAHN 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
00733132615179PrimaryGS10
H373VBH11100239SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132615179007331326151797331326151790733132615179

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery endovascular stent-graft, drug-coatedA non-bioabsorbable tubular implantable device intended to maintain patency and improve luminal diameter of a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries), and that includes a heparin coating intended to prevent thrombotic vessel re-narrowing. It may be intended for implantation in an artery adjacent to the aorta (e.g., iliac, renal arteries), however it is not a dedicated component of an aortoiliac stent-graft assembly; it may additionally be intended for venous implantation. It is comprised of a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge11French
Length10Centimeter
Lumen/Inner Diameter11Millimeter

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
00733132615858GORE-TEX Vascular Graft Pediatric ShuntVT03010LAVT03010LA2017-02-13
00733132615865GORE-TEX Vascular Graft Pediatric ShuntVT04010LAVT04010LA2017-02-13

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