Identity
- Trade Name
- UNI-CLIP FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- The Large Uni-Clip Staple is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled with many choice of size. The Large Uni-Clip Staple is indicated for fixation of bone fractures or for bone reconstruction. The set includes the staples and instruments. FDA UDI
- Model / Reference
- LGUNICPINST FDA UDI
- Description
- The Large Uni-Clip Staple is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled with many choice of size. The Large Uni-Clip Staple is indicated for fixation of bone fractures or for bone reconstruction. The set includes the staples and instruments. FDA UDI
Identifiers
- Catalog Number
- LGUNICPINST FDA UDI
- Primary DI / UDI-DI
- 10381780064435 FDA UDI
- 510(k) Number
- K061594 FDA UDI
- FDA Product Code
- JDR 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
Uni-Clip 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 e55779f2-a856-4bb6-b52d-147a536bc302 38 fields · synced May 30, 2026