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GORE VIABAHN Endoprosthesis

FDA UDI

Class III (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE VIABAHN Endoprosthesis FDA UDI
Generic Name
Peripheral artery endovascular stent-graft, non-medicated FDA UDI
Device Name
VIABAHN SX ENDO 35 13mmX10cm 12Fr 120cmCath FDA UDI
Model / Reference
VBC131002A FDA UDI
Description
VIABAHN SX ENDO 35 13mmX10cm 12Fr 120cmCath FDA UDI

Identifiers

Catalog Number
VBC131002A FDA UDI
Primary DI / UDI-DI
00733132623686 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, non-medicated 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

No

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
Outer Diameter — 13 Millimeter FDA UDI
Length — 10 Centimeter FDA UDI

Category: Peripheral artery endovascular stent-graft, non-medicated

GORE VIABAHN Endoprosthesis by W. L. Gore & Associates, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral artery endovascular stent-graft, non-medicated.

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 55b848e0-8ae4-4750-a27d-7e1e29245761 37 fields · synced Jun 6, 2026