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GORE VIABAHN Endoprosthesis with Heparin

FDA UDI

Class III (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE VIABAHN Endoprosthesis with Heparin FDA UDI
Generic Name
Peripheral artery endovascular stent-graft, drug-coated FDA UDI
Device Name
GORE VIABAHN Endoprosthesis with Heparin 10mmx5cm 8Fr 120cmCath FDA UDI
Model / Reference
VBHR100502A FDA UDI
Description
GORE VIABAHN Endoprosthesis with Heparin 10mmx5cm 8Fr 120cmCath FDA UDI

Identifiers

Catalog Number
VBHR100502A FDA UDI
Primary DI / UDI-DI
00733132646029 FDA UDI
PMA Number
P040037 FDA UDI
P130006 FDA UDI
FDA Product Code
NIP FDA UDI
PFV FDA UDI
GMDN Term
Peripheral artery endovascular stent-graft, drug-coated FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 10 Millimeter FDA UDI
Length — 5 Centimeter FDA UDI
Catheter Gauge — 8 French FDA UDI
Catheter Working Length — 120 Centimeter FDA UDI

Category: Peripheral artery endovascular stent-graft, drug-coated

The GORE VIABAHN Endoprosthesis with Heparin is a peripheral artery endovascular stent-graft designed to maintain patency and improve luminal diameter of a peripheral artery. This device features a heparin coating intended to prevent thrombotic vessel re-narrowing, making it suitable for implantation in an artery adjacent to the aorta, such as the iliac or renal arteries.

Similar devices

Also classified as Peripheral artery endovascular stent-graft, drug-coated.

Cleared under the same submission

P040037 also covers:

P130006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (1)

  • FDA UDI cb83cb4c-cbf8-4ab1-ae32-cfea50d91dc3 37 fields · synced Jul 24, 2026