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OneGuide SS NoMount Driver
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref OGNMDR50SRef OGNMDW67SRef OGNMDR57S
Identity
- Trade Name
- OneGuide SS NoMount Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Tool System EUDAMEDSurgical Instrument System EUDAMED
- Model / Reference
- OGNMDR50S EUDAMEDFDA UDIOGNMDR57S EUDAMEDFDA UDIOGNMDW67S EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000981062 EUDAMEDFDA UDI08809917098856 EUDAMEDFDA UDI08809917098887 EUDAMEDFDA UDI08809917098900 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406TOOLQD EUDAMED88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
OneGuide SS NoMount Driver by Osstem Implant Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000406TOOLQD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
- EUDAMED SRN
- KR-MF-000020006
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (8)
- EUDAMED 9d19287d-0e33-475c-ba55-45f656102ed4 61 fields · synced Aug 2, 2026
- FDA UDI c5ee6e8f-5ef9-4f62-bc4d-2ef9b17bb269 32 fields · synced May 29, 2026
- FDA UDI e5fe1d9a-eb27-49f5-aac2-45519616e7ba 32 fields · synced May 30, 2026
- FDA UDI 13ccc36b-dfad-40e0-8f89-b25ede949048 32 fields · synced May 30, 2026
- FDA UDI 9d77714e-7454-4ac2-bdc7-6d1f0dbf7782 32 fields · synced May 30, 2026
- EUDAMED e6ad3713-b0d5-4119-aadb-4118d0d01a63 61 fields · synced Jul 9, 2026
- EUDAMED 7ea3692f-b967-4bfe-930f-66a0cef97d04 61 fields · synced Aug 2, 2026
- EUDAMED ab8db1ed-489e-46a2-8908-20a32b670963 61 fields · synced Aug 2, 2026