Identity
- Trade Name
- FASTPAK FDA UDI
- Generic Name
- Knee tibia prosthesis trial, single-use FDA UDI
- Device Name
- FASTPAK TIBIAL BASE TRIAL SIZE 1 LEFT FDA UDI
- Model / Reference
- 71443311 FDA UDI
- Description
- FASTPAK TIBIAL BASE TRIAL SIZE 1 LEFT FDA UDI
Identifiers
- Catalog Number
- 71443311 FDA UDI
- Primary DI / UDI-DI
- 00885556747353 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Knee tibia prosthesis trial, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
Category: Knee tibia prosthesis trial, single-use
Fastpak by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee tibia prosthesis trial, single-use.
- FASTPAK — Smith & Nephew, Inc. · Class I
- FASTPAK — Smith & Nephew, Inc. · Class I
- JOURNEY II FASTPAK — Smith & Nephew, Inc. · Class I
- VISIONAIRE FASTPAK — Smith & Nephew, Inc. · Class II
- FASTPAK — Smith & Nephew, Inc. · Class I
- LEGION — Smith & Nephew, Inc. · Class II
- JOURNEY II FASTPAK — Smith & Nephew, Inc. · Class I
- FASTPAK — Smith & Nephew, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI f37843aa-d544-4a14-8eea-cdaff67d14f0 35 fields · synced Jun 8, 2026