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Screw Holder
EUDAMEDFDA UDIClass I (EU MDR)
Ref OSHRRef HOSHRRef OSHMRef OSHR18Ref HSHR18Ref HOSHM
Identity
- Trade Name
- Screw Holder EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OSHR EUDAMEDFDA UDIHSHR18 EUDAMEDFDA UDIHOSHM EUDAMEDFDA UDIOSHR18 EUDAMEDFDA UDIHOSHR EUDAMEDFDA UDIOSHM EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000977607 EUDAMEDFDA UDI08800209372357 EUDAMEDFDA UDI08800209371305 EUDAMEDFDA UDI08809892362812 EUDAMEDFDA UDI08800209371312 EUDAMEDFDA UDI08809892362829 EUDAMEDFDA UDI08809892362805 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 Holder 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 (14)
- EUDAMED 5488086e-c00e-4115-8e76-9a8b42c2791e 61 fields · synced Aug 2, 2026
- FDA UDI 5f759ccc-4305-4782-8dd3-fb25c6e68c25 32 fields · synced May 30, 2026
- FDA UDI 6744ccb9-1fd2-46c9-b09c-e57c775eebe3 32 fields · synced May 30, 2026
- FDA UDI 54cab39b-afb3-4805-9ecf-cfe77f608393 32 fields · synced May 30, 2026
- FDA UDI de2b4714-7dc7-4c4b-8b88-21d41fcc7438 32 fields · synced May 30, 2026
- FDA UDI 7fa20753-404f-4733-b5e2-9df933363ab3 32 fields · synced May 30, 2026
- FDA UDI 71cc385b-7742-4a0e-804c-3d53df59f71b 32 fields · synced May 30, 2026
- FDA UDI 833a00b5-14a6-4758-b31b-b0fc985c6d09 32 fields · synced May 30, 2026
- EUDAMED c042b928-646f-4c6f-b0ea-3a1b483598af 61 fields · synced Jun 20, 2026
- EUDAMED 80cd56ff-7cb3-4ba5-b7c1-729aab456fb7 61 fields · synced Jul 9, 2026
- EUDAMED 02d85731-ee55-48e3-82b6-a5ccb1495908 61 fields · synced Jul 16, 2026
- EUDAMED e840ab57-ceab-4add-b4f3-8417f2ea9801 61 fields · synced Jul 18, 2026
- EUDAMED 0fae32f2-09e0-4f99-b74d-9bfb544aab61 61 fields · synced Jul 26, 2026
- EUDAMED 3863b453-c4e5-4fd5-b20a-94f48917eb00 61 fields · synced Aug 2, 2026