Identity
- Trade Name
- UNI-CP FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- The UNI-CP system includes compression plates, screws, and instruments.The compression plate is indicated for fixation of bone fractures or bone reconstruction. By widening the “eye” on the interaxis of the plate, mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse. The rigidity of the “legs” is obtained using the locking system. FDA UDI
- Model / Reference
- UNICP2SET FDA UDI
- Description
- The UNI-CP system includes compression plates, screws, and instruments.The compression plate is indicated for fixation of bone fractures or bone reconstruction. By widening the “eye” on the interaxis of the plate, mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse. The rigidity of the “legs” is obtained using the locking system. FDA UDI
Identifiers
- Catalog Number
- UNICP2SET FDA UDI
- Primary DI / UDI-DI
- 10381780064480 FDA UDI
- FDA Product Code
- HRS FDA UDIHTY FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
Uni-Cp 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 1a96bf12-1a3b-4708-8c9a-386acb1ddbad 37 fields · synced May 30, 2026