Identity
- Trade Name
- INSTRUMENT FDA UDI
- Generic Name
- Knee tibia prosthesis trial, reusable FDA UDI
- Device Name
- TS TCG Tibial Insert Trial FDA UDI
- Model / Reference
- 5538-T-322X FDA UDI
- Description
- TS TCG Tibial Insert Trial FDA UDI
Identifiers
- Catalog Number
- 5538-T-322X FDA UDI
- Primary DI / UDI-DI
- 07613327521481 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Knee tibia prosthesis trial, reusable 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
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Knee tibia prosthesis trial, reusable
Instrument by Howmedica Osteonics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- JOURNEY — 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 |
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Manufacturer
- Manufacturer
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI f3eb5d1c-205e-411f-9fb3-2ab13605fefd 35 fields · synced May 30, 2026