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Case, Cervical Spine System, Drivers (S9SPINE-CTL - Shukla Spine/ Universal Spi…
EUDAMEDClass I (EU MDR)
Ref SCS034Model SCS036
Identity
- Trade Name
- Case, Cervical Spine System, Drivers (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Device Name
- Case, Spine System, Instruments (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Model / Reference
- SCS036 EUDAMEDSCS034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SCS0340 EUDAMED
- Basic UDI-DI
- ++B756S9SPINECTLCASEGX EUDAMED
- Direct Marketing DI
- +B756SCS0340 EUDAMED
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Category: Instrument tray, reusable
Case, Cervical Spine System, Drivers (S9SPINE-CTL - Shukla Spine/ Universal Spi… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
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Manufacturer's product page: Spine
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 | ++B756S9SPINECTLCASEGX | 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 6aa8e317-0b03-4bde-b5b6-2d47a76c9a99 61 fields · synced Jul 13, 2026