Identity
- Trade Name
- TIBIAXYS® FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- The thermoformed non sterile implant tray is part of the base with reference 159980ND used in the transport and the sterilization of the non sterile implants. The transport and sterilization containers are not intended to maintain sterility. FDA UDI
- Model / Reference
- 159986ND FDA UDI
- Description
- The thermoformed non sterile implant tray is part of the base with reference 159980ND used in the transport and the sterilization of the non sterile implants. The transport and sterilization containers are not intended to maintain sterility. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780042235 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Tibiaxys® by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Newdeal Sas
Sources (1)
- FDA UDI 93c48602-3ba1-4875-a266-327146ef68af 35 fields · synced May 30, 2026