Identity
- Trade Name
- GORE TIPS Set FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- GORE TIPS SET 10Fr 3.4mm / 16Ga 1.65mm FDA UDI
- Model / Reference
- TSET1016 FDA UDI
- Description
- GORE TIPS SET 10Fr 3.4mm / 16Ga 1.65mm FDA UDI
Identifiers
- Catalog Number
- TSET1016 FDA UDI
- Primary DI / UDI-DI
- 00733132657902 FDA UDI
- FDA Product Code
- DYB FDA UDIGBZ FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 10 French FDA UDI
Category: Vascular catheter introduction set, nonimplantablePortosystemic needle set
GORE TIPS Set by W. L. Gore & Associates, Inc — 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 Needle — CREGANNA UNLIMITED COMPANY · 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
- W. L. Gore & Associates, Inc
Sources (1)
- FDA UDI 5a74949e-5e13-466e-b641-2a7f221d297a 36 fields · synced May 30, 2026