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Screw Driver
EUDAMEDFDA UDIClass I (EU MDR)
Ref FRSDW30Ref FRSDM23Ref FRSDR25Ref HFRSDR25
Identity
- Trade Name
- Screw Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- FRSDW30 EUDAMEDFDA UDIFRSDM23 EUDAMEDFDA UDIFRSDR25 EUDAMEDFDA UDIHFRSDR25 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000935454 EUDAMEDFDA UDI08800209393970 EUDAMEDFDA UDI08800209393994 EUDAMEDFDA UDI08800209393987 EUDAMEDFDA UDI08800209366783 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V 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 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
Screw Driver by Osstem Implant Co., Ltd. — Class I — 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 | 88000406CLASSIBS25V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (10)
- EUDAMED c932598c-87c0-4ecd-9ed1-7ac687a9c04d 61 fields · synced Jul 28, 2026
- FDA UDI be854fe3-f5c8-4379-bd8f-70eb741458c8 32 fields · synced May 29, 2026
- FDA UDI 20f25aa2-880e-4f4b-90ac-4d73ad507bd4 32 fields · synced May 30, 2026
- FDA UDI d4a8302a-eff5-4205-824f-28824c613c75 32 fields · synced May 30, 2026
- FDA UDI 82ad6942-ad76-425d-ba2a-6b04af9f10b5 32 fields · synced May 30, 2026
- FDA UDI 2cf3b121-25ae-49e9-8ef7-b3993a282fde 32 fields · synced May 30, 2026
- EUDAMED 6d995280-095f-470d-b350-faddaa3a2b13 61 fields · synced Jul 11, 2026
- EUDAMED b5e99f61-1190-4b76-b286-e4720a097c80 61 fields · synced Jul 12, 2026
- EUDAMED ac03a3bd-3e6b-44ca-b552-68b54cdc3cdd 61 fields · synced Jul 17, 2026
- EUDAMED d45e3d2b-52a6-44e0-8b9a-bfeff867197e 61 fields · synced Jul 28, 2026