Identity
- Trade Name
- CALCANEA™ FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- The 2.2mm drilling sleeve, with a hexagonal attachment, is screwed to the plate holes. It allows axial drilling and perfect insertion of the variable angle locking screws as well as protection of the soft tissues while drilling. FDA UDI
- Model / Reference
- 129135ND FDA UDI
- Description
- The 2.2mm drilling sleeve, with a hexagonal attachment, is screwed to the plate holes. It allows axial drilling and perfect insertion of the variable angle locking screws as well as protection of the soft tissues while drilling. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780042990 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical drill guide, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI 2fa6f0b5-71a2-4a3d-9395-ca63277f1aa5 35 fields · synced Jun 1, 2026