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Osteotome Assy, Z Shaped, 1/2" Reach, .313" Wide (S9KNEE Shukla Knee / Universa…
EUDAMEDClass I (EU MDR)
Ref SOS001-09Model SOS001-05
Identity
- Trade Name
- Osteotome Assy, Z Shaped, 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 EUDAMEDSOS001-09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- SOS001090 EUDAMED
- Basic UDI-DI
- ++B756S9KNEEOSTEQ EUDAMED
- Direct Marketing DI
- SOS001090 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, Z Shaped, 1/2" Reach, .313" Wide (S9KNEE Shukla Knee / Universa… 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 21c37c63-f9d9-43a6-bd9d-fc6db688166d 61 fields · synced Oct 6, 2026