Identity
- Trade Name
- CALCANEA FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Full Calcanea Plate Instrument and Implant Set FDA UDI
- Model / Reference
- CALCINSTSET FDA UDI
- Description
- Full Calcanea Plate Instrument and Implant Set FDA UDI
Identifiers
- Catalog Number
- CALCINSTSET FDA UDI
- Primary DI / UDI-DI
- 10381780125853 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Calcanea by Newdeal Sas — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI 74c765b7-c4b3-4977-a9c5-307f1343736b 36 fields · synced Jun 8, 2026