Identity
- Trade Name
- Re-tap EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- ORTR EUDAMEDFDA UDIHRTR18 EUDAMEDFDA UDIORTW EUDAMEDFDA UDIHORTW EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000979823 EUDAMEDFDA UDI08800209372104 EUDAMEDFDA UDI08809892362621 EUDAMEDFDA UDI08800209371282 EUDAMEDFDA UDI08809892362607 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
Re-tap 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 86c1bde8-5483-4528-81df-c5406ee89efb 61 fields · synced Sep 17, 2026
- FDA UDI 5e27e721-eb95-4f1e-9496-b4fb6af8e36c 32 fields · synced May 30, 2026
- FDA UDI 17dfe34b-156e-4a12-9546-d20e6091a3f8 32 fields · synced May 30, 2026
- FDA UDI b3604d49-71ca-49cf-ac38-44a8a1394c07 32 fields · synced May 30, 2026
- FDA UDI 1d5e557e-865f-44fc-929e-57b41bc0d397 32 fields · synced May 30, 2026
- FDA UDI 77052ba6-bdbb-4240-87f2-84dd15f40c3a 32 fields · synced May 30, 2026
- EUDAMED dab74f4e-92e7-4a5b-b2b1-0602f8a0ae4a 61 fields · synced Jul 19, 2026
- EUDAMED 75d0d669-e8a4-4df8-a246-867487754f91 61 fields · synced Jul 23, 2026
- EUDAMED e13df4dc-64e6-4b2f-aefc-2aaa7bdf3eed 61 fields · synced Jul 27, 2026
- EUDAMED 44ce21c7-aef5-4044-8615-404407527588 61 fields · synced Sep 17, 2026