← Back to catalogue
Chisel FR-047 - chisel screwdriver tip
EUDAMEDClass IIa (EU MDR)
Ref FR-047 endocon catalogue Model chisel system for prosthesis removal
by endocon GmbH
Identity
- Trade Name
- Chisel FR-047 - chisel screwdriver tip EUDAMED
- Device Name
- OrthoClast EUDAMED
- Model / Reference
- chisel system for prosthesis removal EUDAMEDFR-047 endocon catalogue EUDAMED
Identifiers
- Primary DI / UDI-DI
- 42514018001196 EUDAMED
- Basic UDI-DI
- 425140189970900096 EUDAMED
- Direct Marketing DI
- 42514018001196 EUDAMED
- EMDN Code
- Z12139002 PROSTHETIC CEMENT REMOVAL EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The Chisel FR-047, also known as OrthoClast, is a Class IIa medical device designed for the removal of prosthetic devices. This screwdriver tip feature allows for precise and efficient removal of screws in orthopedic procedures, making it an essential tool for healthcare professionals.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 425140189970900096 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- endocon GmbH
- EUDAMED SRN
- DE-MF-000020703
Sources (1)
- EUDAMED 1db443c7-d7a9-4ab1-b6ba-6a911916835a 61 fields · synced Jul 23, 2026