Identity
- Trade Name
- Chisel handle FDA UDI
- Generic Name
- Orthopaedic osteotome handle FDA UDI
- Device Name
- A hand-held instrument used to maintain and hold chisel blade of different designs (straight, curved, offset, etc.). The exchange of the chisel blades occur simply by tightening and loosening the screw by use of the Allen key. In case the chisel blade remains stocked, the slap hammer can be screwed at the handle extremity. This is a reusable device. FDA UDI
- Model / Reference
- T14584 FDA UDI
- Description
- A hand-held instrument used to maintain and hold chisel blade of different designs (straight, curved, offset, etc.). The exchange of the chisel blades occur simply by tightening and loosening the screw by use of the Allen key. In case the chisel blade remains stocked, the slap hammer can be screwed at the handle extremity. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- T14584 FDA UDI
- Primary DI / UDI-DI
- 07640187910513 FDA UDI
- FDA Product Code
- FZO FDA UDI
- GMDN Term
- Orthopaedic osteotome handle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- 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
Category: Orthopaedic osteotome handle
Chisel handle by MPS Micro Precision Systems AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic osteotome handle.
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- Zavation — ZAVATION · Class II
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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
- MPS Micro Precision Systems AG
Sources (1)
- FDA UDI 045c9c38-2299-425d-9c35-b94b833d79b1 35 fields · synced Jun 1, 2026