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Distalock Femur Reconstruction Screw Ø6.4×115 mm
EUDAMEDClass IIb (EU MDR)
Ref 303-064-115Model Femur Reconstruction Screw
Identity
- Trade Name
- Distalock Femur Reconstruction Screw Ø6.4×115 mm EUDAMED
- Device Name
- Distalock Femur Reconstruction Screw Ø6.4×115 mm EUDAMED
- Model / Reference
- Femur Reconstruction Screw EUDAMED303-064-115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682704634204 EUDAMED
- Basic UDI-DI
- B-08682704634204 EUDAMED
- EMDN Code
- P09120604 OSTEOSYNTHESIS NAIL-SCREW SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
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
Distalock Femur Reconstruction Screw Ø6.4×115 mm by Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08682704634204 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş.
- EUDAMED SRN
- TR-MF-000022268
Sources (1)
- EUDAMED ebf29bd5-fe3f-4ec9-9e60-d86ccb3345dd 61 fields · synced Jun 19, 2026