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Driver Assy, Male, Hex, Reverse Captive, 3.5mm : For S9SPINE , Spc. Order (S9SP…
EUDAMEDClass I (EU MDR)
Ref SDR707CModel SDR701
Identity
- Trade Name
- Driver Assy, Male, Hex, Reverse Captive, 3.5mm : For S9SPINE , Spc. Order (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Device Name
- Driver Assy, Male, Hex, 2 mm EUDAMED
- Model / Reference
- SDR701 EUDAMEDSDR707C EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SDR707C0 EUDAMED
- Basic UDI-DI
- ++B756S9SPINECTLSSK3 EUDAMED
- Direct Marketing DI
- +B756SDR707C0 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, Hex, Reverse Captive, 3.5mm : For S9SPINE , Spc. Order (S9SP… 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 c8face9b-f5fa-4d17-8691-929adf293dd3 61 fields · synced Oct 7, 2026