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Driver, Rigid, Cruciform, 3.8 mm (S9MAXI - Shukla MAXI/ Universal Large Screw E…
EUDAMEDClass I (EU MDR)
Ref SDR254Model SDR240
Identity
- Trade Name
- Driver, Rigid, Cruciform, 3.8 mm (S9MAXI - Shukla MAXI/ Universal Large Screw Extraction Solution) EUDAMED
- Device Name
- Driver, Rigid, Hex, 3 mm (S9MAXI - Shukla MAXI/ Universal Large Screw Extraction Solution) EUDAMED
- Model / Reference
- SDR240 EUDAMEDSDR254 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SDR2540 EUDAMED
- Basic UDI-DI
- ++B756S9MAXISS6C EUDAMED
- Direct Marketing DI
- +B756SDR2540 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, Rigid, Cruciform, 3.8 mm (S9MAXI - Shukla MAXI/ Universal Large Screw E… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
Manufacturer's product page: SHUKLA Trauma Maxi
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 | ++B756S9MAXISS6C | 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 62512f6e-0713-48f4-8f28-82d11bb71a18 61 fields · synced Oct 7, 2026