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Distalock Elastic Intramedullary Nail Ø2×320 mm
EUDAMEDClass IIb (EU MDR)
Ref 260-320-020Model Elastic Intramedullary Nail
Identity
- Trade Name
- Distalock Elastic Intramedullary Nail Ø2×320 mm EUDAMED
- Device Name
- Distalock Elastic Intramedullary Nail Ø2×320 mm EUDAMED
- Model / Reference
- Elastic Intramedullary Nail EUDAMED260-320-020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682704634259 EUDAMED
- Basic UDI-DI
- B-08682704634259 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS 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 Elastic Intramedullary Nail Ø2×320 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-08682704634259 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş.
- EUDAMED SRN
- TR-MF-000022268
Sources (1)
- EUDAMED 509d3691-1a64-41f7-93c1-af7ae9d5e633 61 fields · synced Oct 6, 2026