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Distalock PFN Locking Sliding Compression Screw Ø11×100 mm
EUDAMEDClass IIb (EU MDR)
Ref 213-110-100Model PFN Locking Sliding Compression Screw
Identity
- Trade Name
- Distalock PFN Locking Sliding Compression Screw Ø11×100 mm EUDAMED
- Device Name
- Distalock PFN Locking Sliding Compression Screw Ø11×100 mm EUDAMED
- Model / Reference
- PFN Locking Sliding Compression Screw EUDAMED213-110-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682704633252 EUDAMED
- Basic UDI-DI
- B-08682704633252 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 Sliding Compression Screw Ø11×100 mm by Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş. — Class IIb — MDD — listed in EUDAMED
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-08682704633252 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş.
- EUDAMED SRN
- TR-MF-000022268
Sources (1)
- EUDAMED 87790d0c-b494-49ac-9f7d-645b9eada793 61 fields · synced Jul 26, 2026