Identity
- Trade Name
- GORE VIATORR TIPS Endoprosthesis FDA UDI
- Generic Name
- Endoprosthetic portosystemic shunt FDA UDI
- Device Name
- VIATORR ENDOPROTHESIS 10MMX5/2CM VIATORR FDA UDI
- Model / Reference
- PTB105275 FDA UDI
- Description
- VIATORR ENDOPROTHESIS 10MMX5/2CM VIATORR FDA UDI
Identifiers
- Catalog Number
- PTB105275 FDA UDI
- Primary DI / UDI-DI
- 00733132609802 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 10 Millimeter FDA UDILength — 5 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:
- GORE VIATORR TIPS Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE VIATORR TIPS Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE VIATORR TIPS Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE VIATORR TIPS Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE VIATORR TIPS Endoprosthesis — W. L. GORE & ASSOCIATES, INC
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 f0362e23-aa2d-4030-bc8c-858a7b2ff662 38 fields · synced Jun 8, 2026