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Driver Assy, Male, Square, 4 mm for Orthofix (S9SPINE-CTL - Shukla Spine/ Unive…
EUDAMEDClass I (EU MDR)
Ref SDR773Model SDR701
Identity
- Trade Name
- Driver Assy, Male, Square, 4 mm for Orthofix (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Device Name
- Driver Assy, Male, Hex, 2 mm EUDAMED
- Model / Reference
- SDR701 EUDAMEDSDR773 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SDR7730 EUDAMED
- Basic UDI-DI
- ++B756S9SPINECTLSSK3 EUDAMED
- Direct Marketing DI
- +B756SDR7730 EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Driver Assy, Male, Square, 4 mm for Orthofix (S9SPINE-CTL - Shukla Spine/ Unive… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B756S9SPINECTLSSK3 | Class I | Active |
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Manufacturer
- Manufacturer
- S. S. White Technologies Inc/DBA Shukla Medical
- EUDAMED SRN
- US-MF-000007058
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 45c1bf08-5b77-4790-a307-a468cda17ff8 61 fields · synced Oct 6, 2026