Identity
- Trade Name
- CALCANEA™ FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- The right bender is used to shape the plate according to the bone configuration, together with the left bender referenced 129140ND. FDA UDI
- Model / Reference
- 129139ND FDA UDI
- Description
- The right bender is used to shape the plate according to the bone configuration, together with the left bender referenced 129140ND. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780051954 FDA UDI
- FDA Product Code
- HXW FDA UDI
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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 3967e551-3a6a-42f8-a42c-b9030a914824 35 fields · synced May 30, 2026