Identity
- Trade Name
- TIBIAXYS® FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- The stainless steel assembled implant base is part of the complete container with reference 159990ND used in the transport and the sterilization of the non sterile implants and associated instruments. It includes one base with four wedges with reference 119909ND, one screw rack with reference 159982ND, one rack cover with reference 159984ND, one implant tray with reference 159986ND and one tray cover with reference 159988ND. The transport and sterilization containers are not intended to maintain sterility. FDA UDI
- Model / Reference
- 159980ND FDA UDI
- Description
- The stainless steel assembled implant base is part of the complete container with reference 159990ND used in the transport and the sterilization of the non sterile implants and associated instruments. It includes one base with four wedges with reference 119909ND, one screw rack with reference 159982ND, one rack cover with reference 159984ND, one implant tray with reference 159986ND and one tray cover with reference 159988ND. The transport and sterilization containers are not intended to maintain sterility. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780042211 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
Yes
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 5745a56e-d4d7-4949-b0fe-b78f9fb20027 35 fields · synced Jun 8, 2026