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Reverse Driver
EUDAMEDFDA UDIClass I (EU MDR)
Ref ORVDMLRef ORVDRLRef HRVDRSRef HRVDRL
Identity
- Trade Name
- Reverse Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDISurgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- ORVDML EUDAMEDFDA UDIHRVDRS EUDAMEDFDA UDIHRVDRL EUDAMEDFDA UDIORVDRL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800000979724 EUDAMEDFDA UDI08809917144812 EUDAMEDFDA UDI08809917144805 EUDAMEDFDA UDI08809892362638 EUDAMED08809892362645 EUDAMED
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMEDQ010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, single-use FDA UDISurgical 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
Yes
FDA UDIFDA 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
Reverse 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 (8)
- EUDAMED ad836545-ee50-450c-8c4f-45dcfdcb9305 61 fields · synced Aug 1, 2026
- FDA UDI de661ccc-7fa0-44d8-a5f6-eaa6e125e4e3 32 fields · synced May 30, 2026
- FDA UDI bc24fa5f-2dff-4168-aff4-ef6286b33962 32 fields · synced May 30, 2026
- FDA UDI 953fcb94-88da-46a9-a73b-985936f0018c 32 fields · synced May 30, 2026
- EUDAMED 291116a0-d5d4-452c-a4cc-7887e6ced6ec 61 fields · synced Jul 10, 2026
- EUDAMED 8b913779-584a-4fcf-bb0b-f88622ce421b 61 fields · synced Jul 18, 2026
- EUDAMED 406f04bf-8f38-4240-bb90-3edffa6454f3 61 fields · synced Jul 30, 2026
- EUDAMED 15a7bd7b-8e7e-4333-82dc-1bc18908f824 61 fields · synced Aug 1, 2026