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Extension Assy, 6" (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal …
EUDAMEDClass I (EU MDR)
Ref SXN008Model SXN007
Identity
- Trade Name
- Extension Assy, 6" (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Device Name
- Extension Assy, 4" (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Model / Reference
- SXN007 EUDAMEDSXN008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SXN0080 EUDAMED
- Basic UDI-DI
- ++B756S9SPINECTLXMN EUDAMED
- Direct Marketing DI
- +B756SXN0080 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER 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
Extension Assy, 6" (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal … 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 | ++B756S9SPINECTLXMN | 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 cbc99b3c-607a-43b5-9d9d-f0dc7ff4c997 61 fields · synced Jun 19, 2026