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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 ENDOPROTHESIS 8MMX8/2CM VIATORR FDA UDI
Model / Reference
PTB088275 FDA UDI
Description
VIATORR ENDOPROTHESIS 8MMX8/2CM VIATORR FDA UDI

Identifiers

Catalog Number
PTB088275 FDA UDI
Primary DI / UDI-DI
00733132609789 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
Not 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 — 8 Millimeter FDA UDI
Length — 8 Centimeter FDA UDI

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

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 3da3221d-68b5-4de2-9f5d-b5e45f93f700 38 fields · synced Jun 6, 2026