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Distalock Long PFN Intramedullary Nail Ø10×360 mm Right
EUDAMEDClass IIb (EU MDR)
Ref 204-100-360Model Distalock Long PFN Intramedullary Nail
Identity
- Trade Name
- Distalock Long PFN Intramedullary Nail Ø10×360 mm Right EUDAMED
- Device Name
- Distalock Long PFN Intramedullary Nail Ø10×360 mm Right EUDAMED
- Model / Reference
- Distalock Long PFN Intramedullary Nail EUDAMED204-100-360 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682704633788 EUDAMED
- Basic UDI-DI
- B-08682704633788 EUDAMED
- EMDN Code
- P09120202 INTRAMEDULLARY NAILS IN COMPLEX 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 Long PFN Intramedullary Nail Ø10×360 mm Right 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-08682704633788 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş.
- EUDAMED SRN
- TR-MF-000022268
Sources (1)
- EUDAMED 37f3e32c-e1ee-4c86-9dba-9806a5a58ed7 61 fields · synced Oct 6, 2026