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Distalock PFN Locking Screw Ø5×38 mm
EUDAMEDClass IIb (EU MDR)
Ref 243-050-038Model PFN Locking Screw
Identity
- Trade Name
- Distalock PFN Locking Screw Ø5×38 mm EUDAMED
- Device Name
- Distalock PFN Locking Screw Ø5×38 mm EUDAMED
- Model / Reference
- PFN Locking Screw EUDAMED243-050-038 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682704633504 EUDAMED
- Basic UDI-DI
- B-08682704633504 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 PFN Locking Screw Ø5×38 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-08682704633504 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş.
- EUDAMED SRN
- TR-MF-000022268
Sources (1)
- EUDAMED e9a62f6d-3030-433c-9685-7b62d18364aa 61 fields · synced Jul 10, 2026