Identity
- Trade Name
- LARGE QWIX® FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- The implant set is used in the transport and the sterilization of the LARGE QWIX® 5.5mm and 7.5mm screw associated instruments and non sterile implants. It includes one implant tray base with reference 121961ND, one 7.5mm screw rack with reference 121975ND and one 5.5mm screw rack with reference 121955ND. The transport and sterilization containers are not intended to maintain sterility. FDA UDI
- Model / Reference
- 121960ND FDA UDI
- Description
- The implant set is used in the transport and the sterilization of the LARGE QWIX® 5.5mm and 7.5mm screw associated instruments and non sterile implants. It includes one implant tray base with reference 121961ND, one 7.5mm screw rack with reference 121975ND and one 5.5mm screw rack with reference 121955ND. The transport and sterilization containers are not intended to maintain sterility. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780054962 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
Large Qwix® 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 feb77198-d5e4-4445-8f30-2650b2f59c5c 35 fields · synced May 30, 2026