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Distalock PFN Set Screw Ø8×15 mm
EUDAMEDClass IIb (EU MDR)
Ref 233-000-015Model PFN Set Screw
Identity
- Trade Name
- Distalock PFN Set Screw Ø8×15 mm EUDAMED
- Device Name
- Distalock PFN Set Screw Ø8×15 mm EUDAMED
- Model / Reference
- PFN Set Screw EUDAMED233-000-015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682704633436 EUDAMED
- Basic UDI-DI
- B-08682704633436 EUDAMED
- EMDN Code
- P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES 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 Set Screw Ø8×15 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-08682704633436 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş.
- EUDAMED SRN
- TR-MF-000022268
Sources (1)
- EUDAMED c2b0d0f0-9835-413f-babc-91d435adf5f1 61 fields · synced Jun 19, 2026