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NoMount Driver
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SSNMDLRef USNMDWSRef USNMDMSRef USNMDWL
Identity
- Trade Name
- NoMount Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Tool System EUDAMEDSurgical Instrument System EUDAMED
- Model / Reference
- SSNMDL EUDAMEDFDA UDIUSNMDMS EUDAMEDFDA UDIUSNMDWS EUDAMEDFDA UDIUSNMDWL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000965482 EUDAMEDFDA UDI08809917076366 EUDAMEDFDA UDI08809917076403 EUDAMEDFDA UDI08809917076397 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
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 381007a5-c2e4-459c-a828-6895a8c64674 61 fields · synced Jul 19, 2026
- FDA UDI f97f3c44-66db-4ab1-b38e-17ba2569b3a9 32 fields · synced May 29, 2026
- FDA UDI 664fe190-16e0-445b-919b-9cebb356777b 32 fields · synced May 29, 2026
- FDA UDI 401d2d4e-d254-4b80-86e4-0a7642f35818 32 fields · synced May 29, 2026
- FDA UDI 08c4ccf4-36b9-493f-842e-3628bb84168e 32 fields · synced May 30, 2026
- EUDAMED 884cf8b8-7821-438e-a3ac-9ee0cec98079 61 fields · synced Jul 9, 2026
- EUDAMED 1cde2479-8003-42c7-9937-d964ea319b04 61 fields · synced Jul 18, 2026
- EUDAMED 8cd9ae63-b124-4478-8afb-52aab63844e7 61 fields · synced Jul 19, 2026