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Rigid Outer Driver
EUDAMEDFDA UDIClass I (EU MDR)
Ref ORDRSRef HRDRSRef ORDMLRef ORDRLRef ORDWSRef ORDWLRef HRDWLRef HRDMS
Identity
- Trade Name
- Rigid Outer Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- ORDRS EUDAMEDFDA UDIORDWL EUDAMEDFDA UDIORDML EUDAMEDFDA UDIORDRL EUDAMEDFDA UDIORDWS EUDAMEDFDA UDIHRDMS EUDAMEDFDA UDIHRDRS EUDAMEDFDA UDIHRDWL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800040607786 EUDAMEDFDA UDI08809892362386 EUDAMEDFDA UDI08809892362393 EUDAMEDFDA UDI08809892362355 EUDAMEDFDA UDI08809892362379 EUDAMEDFDA UDI08809892362409 EUDAMEDFDA UDI08800209371855 EUDAMEDFDA UDI08800209371879 EUDAMEDFDA UDI08800209371886 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
Rigid Outer 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 (18)
- EUDAMED 9f83ecbd-e465-4b72-9bc7-ccbd3d20c5b7 61 fields · synced Aug 1, 2026
- FDA UDI 040e8108-bf34-4b27-a604-82806c2535e2 32 fields · synced May 29, 2026
- FDA UDI 69d3ec78-ad39-499d-ab05-5cc21d2e35f2 32 fields · synced May 30, 2026
- FDA UDI 9a58569b-88e4-4743-bba8-5aff8ff6c866 32 fields · synced May 30, 2026
- FDA UDI 131bbcac-e286-4eb4-9e8d-51a9fba2f377 32 fields · synced May 30, 2026
- FDA UDI c0e7be05-6a76-46fb-b19f-e33e98bc3cb4 32 fields · synced May 30, 2026
- FDA UDI af7d3549-12a6-4412-8f32-3ec3a79eea8d 32 fields · synced May 30, 2026
- FDA UDI 0b5b4a92-6a5c-472f-bbc0-5f60d24eb348 32 fields · synced May 30, 2026
- FDA UDI c6defd34-ad79-4998-ab01-2f5094194576 32 fields · synced May 30, 2026
- FDA UDI 719a6724-f85e-4c49-9d3b-45514eeaa3c3 32 fields · synced May 30, 2026
- EUDAMED c3785db3-9f83-439e-a41c-88ccadd95af1 61 fields · synced Jun 20, 2026
- EUDAMED c9b6da54-633f-4b01-b70d-4628289b1a23 61 fields · synced Jul 9, 2026
- EUDAMED 4364c683-3657-4af8-b54c-620e3cb49f94 61 fields · synced Jul 10, 2026
- EUDAMED 0882b19f-5a7c-4eea-b20a-1b48251aadb8 61 fields · synced Jul 22, 2026
- EUDAMED 9d066c7b-78b9-4843-bd92-46f4d25fef16 61 fields · synced Jul 25, 2026
- EUDAMED 8a201f71-587b-48bf-b19c-610941a675e0 61 fields · synced Jul 26, 2026
- EUDAMED c061de44-d37b-4a70-a8f3-849ecaaf27d7 61 fields · synced Jul 28, 2026
- EUDAMED ebf9cbb1-6082-4938-917a-39de0de0abf9 61 fields · synced Aug 1, 2026