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Wrench, Double Open End, 7/32" & 9/32" (S9SPINE-CTL - Shukla Spine/ Universal S…
EUDAMEDClass I (EU MDR)
Ref SWR003
Identity
- Trade Name
- Wrench, Double Open End, 7/32" & 9/32" (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Device Name
- Wrench, Double Open End, 7/32" & 9/32" (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Model / Reference
- SWR003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SWR0030 EUDAMED
- Basic UDI-DI
- ++B756S9SPINECTLWRKD EUDAMED
- Direct Marketing DI
- +B756SWR0030 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
Wrench, Double Open End, 7/32" & 9/32" (S9SPINE-CTL - Shukla Spine/ Universal S… 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 | ++B756S9SPINECTLWRKD | 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 1e333002-a7ad-49c6-ad41-2e89154b590b 61 fields · synced Jul 9, 2026