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GORE VIATORR TIPS Endoprosthesis

FDA UDI

Class III (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE VIATORR TIPS Endoprosthesis FDA UDI
Generic Name
Endoprosthetic portosystemic shunt FDA UDI
Device Name
VIATORR TIPS ENDO CX 8-10mmX8cm/2cm 10Fr FDA UDI
Model / Reference
PTB8108275 FDA UDI
Description
VIATORR TIPS ENDO CX 8-10mmX8cm/2cm 10Fr FDA UDI

Identifiers

Catalog Number
PTB8108275 FDA UDI
Primary DI / UDI-DI
00733132635047 FDA UDI
PMA Number
P040027 FDA UDI
FDA Product Code
MIR FDA UDI
GMDN Term
Endoprosthetic portosystemic shunt 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
Catheter Gauge — 10 French FDA UDI
Length — 2 Centimeter FDA UDI
Length — 8 Centimeter FDA UDI
Lumen/Inner Diameter — 10 Millimeter FDA UDI

Category: Endoprosthetic portosystemic shunt

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

Similar devices

Also classified as Endoprosthetic portosystemic shunt.

Cleared under the same submission

P040027 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 e128b5ba-166d-40ad-be5e-beb497fa2fb7 37 fields · synced May 31, 2026