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 RO 8mmX2.5cm 8Fr 120cmCath FDA UDI
Model / Reference: VBCR080202A FDA UDI
Description: VIABAHN SX ENDO 35 RO 8mmX2.5cm 8Fr 120cmCath FDA UDI

Identifiers

Catalog Number: VBCR080202A FDA UDI
Primary DI / UDI-DI: 00733132623495 FDA UDI
PMA Number: P040037 FDA UDI
P130006 FDA UDI
FDA Product Code: PFV FDA UDI
NIP 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

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: Length — 2.5 Centimeter FDA UDI
Lumen/Inner Diameter — 8 Millimeter 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

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: W. L. Gore & Associates, Inc

Sources (1)

FDA UDI 4b1defa6-f41c-4341-a862-3bacfe5f0786 37 fields · synced May 30, 2026

GORE VIABAHN Endoprosthesis

Identity

Identifiers

Classification

Clinical & Handling

Dimensions & Sizes

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)