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Osteotome Assy, Retrograde, 1/2" Reach, .313" Wide (S9KNEE Shukla Knee / Univer…
EUDAMEDClass I (EU MDR)
Ref SOS001-05
Identity
- Trade Name
- Osteotome Assy, Retrograde, 1/2" Reach, .313" Wide (S9KNEE Shukla Knee / Universal Knee Implant Extraction System) EUDAMED
- Device Name
- Osteotome Assy, Retrograde, 1/2" Reach, .313" Wide (S9KNEE Shukla Knee / Universal Knee Implant Extraction System) EUDAMED
- Model / Reference
- SOS001-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SOS001050 EUDAMED
- Basic UDI-DI
- ++B756S9KNEEOSTEQ EUDAMED
- Direct Marketing DI
- +B756SOS001050 EUDAMED
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, 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
Osteotome Assy, Retrograde, 1/2" Reach, .313" Wide (S9KNEE Shukla Knee / Univer… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
Manufacturer's product page: Knee
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 | ++B756S9KNEEOSTEQ | 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 70f4dfe3-0979-406f-960d-21ea37db4dcd 61 fields · synced Jun 18, 2026