Identity
- Trade Name
- CALCANEA™ FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- The insert is part of the container with reference 129950ND used in the transport and the sterilization of the associated instruments. The transport and sterilization containers are not intended to maintain sterility. FDA UDI
- Model / Reference
- 129952ND FDA UDI
- Description
- The insert is part of the container with reference 129950ND used in the transport and the sterilization of the associated instruments. The transport and sterilization containers are not intended to maintain sterility. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780042174 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
Calcanea™ 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 7891b896-e936-4b8c-884a-999b5b462e1f 35 fields · synced May 30, 2026