Identity
- Trade Name
- Gore TIPS Needle FDA UDI
- Generic Name
- Portosystemic needle set FDA UDI
- Device Name
- Gore TIPS Needle FDA UDI
- Model / Reference
- TNDL1656 FDA UDI
- Description
- Gore TIPS Needle FDA UDI
Identifiers
- Catalog Number
- TNDL1656 FDA UDI
- Primary DI / UDI-DI
- 05391526210000 FDA UDI
- FDA Product Code
- DYB FDA UDIGBZ FDA UDI
- GMDN Term
- Portosystemic needle set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI878.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 16 Gauge FDA UDI
Category: Portosystemic needle set
Gore TIPS Needle by Creganna Unlimited Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Portosystemic needle set.
- Traveler — Argon Medical Devices, Inc. · Class II
- GORE TIPS Set — W. L. GORE & ASSOCIATES, INC · Class II
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
- Creganna Unlimited Company
Sources (1)
- FDA UDI 8775bdd8-1da8-4c81-80ab-4475d18e2ba1 36 fields · synced May 30, 2026