GORE VIABIL Biliary Endoprosthesis

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name: GORE VIABIL Biliary Endoprosthesis FDA UDI
Generic Name: Polymer-metal biliary stent, non-bioabsorbable FDA UDI
Device Name: GORE VIABIL BILIARY ENDO 8mmX10cm 10Fr FDA UDI
Model / Reference: VN0810040 FDA UDI
Description: GORE VIABIL BILIARY ENDO 8mmX10cm 10Fr FDA UDI

Identifiers

Catalog Number: VN0810040 FDA UDI
Primary DI / UDI-DI: 00733132615650 FDA UDI
510(k) Number: K041423 FDA UDI
K081184 FDA UDI
FDA Product Code: FGE FDA UDI
GMDN Term: Polymer-metal biliary stent, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5010 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: Catheter Gauge — 10 French FDA UDI
Length — 10 Centimeter FDA UDI
Lumen/Inner Diameter — 8 Millimeter FDA UDI

Category: Polymer-metal biliary stent, non-bioabsorbable

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

Similar devices

Also classified as Polymer-metal biliary stent, non-bioabsorbable.

WallFlex™ Biliary Transhepatic — Boston Scientific · Class II
WallFlex™ — Boston Scientific · Class II
WallFlex™ Biliary Transhepatic — Boston Scientific · Class II
WallFlex™ Biliary — Boston Scientific · Class II
WallFlex™ — Boston Scientific · Class II
WallFlex™ — Boston Scientific · Class II
WallFlex Biliary — Boston Scientific · Class II
WALLSTENT™ RX BILIARY — Boston Scientific · Class II

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 II	Pending data

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Manufacturer

Manufacturer: W. L. Gore & Associates, Inc

Sources (1)

FDA UDI ece8e5ee-3afb-49d0-b580-d4e447e2688b 37 fields · synced Jun 1, 2026