Identity
- Trade Name
- OSSKAR Kit EUDAMEDOSSKAR FDA UDI
- Generic Name
- Operating table patient positioning set, reusable FDA UDI
- Device Name
- OSSKAR (Oxford Stress System for Knee Arthroplasty Radiographs) EUDAMED
- Model / Reference
- 0197-00-00 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700751500275 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700751501976Y EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Operating table patient positioning set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating table patient positioning set, reusable
Osskar by Askorn Medical — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Askorn Medical
Sources (2)
- FDA UDI d327f3be-6a99-4351-adcd-ad0230e9cb63 32 fields · synced Jun 18, 2026
- EUDAMED f74ecd9e-07a6-49e3-ae92-3dc39f4abb3b 61 fields · synced Jun 18, 2026