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GORE VIABAHN Endoprosthesis with Heparin

FDA UDIEUDAMED

Class III (US FDA UDI)

Ref PACR080202E

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE® VIABAHN® Endoprosthesis EUDAMED
GORE VIABAHN Endoprosthesis with Heparin FDA UDI
Generic Name
Peripheral artery endovascular stent-graft, drug-coated FDA UDI
Device Name
GORE® VIABAHN® Endoprosthesis EUDAMED
GORE VIABAHN Endoprosthesis with Heparin 10mmx15cm 8Fr 120cmCath FDA UDI
Model / Reference
PACR080202E EUDAMED
VBHR101502A FDA UDI
Description
GORE VIABAHN Endoprosthesis with Heparin 10mmx15cm 8Fr 120cmCath FDA UDI

Identifiers

Catalog Number
VBHR101502A FDA UDI
Primary DI / UDI-DI
00733132627370 EUDAMED
00733132646067 FDA UDI
Basic UDI-DI
B-00733132627370 EUDAMED
PMA Number
P040037 FDA UDI
P130006 FDA UDI
FDA Product Code
NIP FDA UDI
PFV FDA UDI
EMDN Code
P0704020203 PERIPHERAL VASCULAR DRUG ELUTING STENTS (DES) EUDAMED
GMDN Term
Peripheral artery endovascular stent-graft, drug-coated FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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 — 15 Centimeter FDA UDI
Catheter Gauge — 8 French FDA UDI
Catheter Working Length — 120 Centimeter FDA UDI

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

GORE VIABAHN Endoprosthesis with Heparin by W. L. Gore & Associates, Inc — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED

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 (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (2)

  • FDA UDI 9d1da0ec-b5d5-49b2-98cc-c68345fc3991 37 fields · synced Sep 17, 2026
  • EUDAMED 308d0670-4412-465a-a6d7-03dbda14c02b 61 fields · synced Sep 17, 2026