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Orthodontic Screw Hand Driver
EUDAMEDFDA UDIClass I (EU MDR)
Ref OSTDARef HSSTDARef HOSTDA
Identity
- Trade Name
- Orthodontic Screw Hand Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OSTDA EUDAMEDFDA UDIHSSTDA EUDAMEDFDA UDIHOSTDA EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800040608400 EUDAMEDFDA UDI08800209375181 EUDAMEDFDA UDI08800209371602 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
Orthodontic Screw Hand 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 (6)
- EUDAMED dca5b24d-7cca-4a59-b8a0-bc6f92f6b8da 61 fields · synced Jul 25, 2026
- FDA UDI f063d088-919a-44d6-9613-85162aea96b7 32 fields · synced May 27, 2026
- FDA UDI ab16a4ea-d444-4ab5-82b3-4161f4cae076 32 fields · synced May 27, 2026
- FDA UDI bddb622d-2c89-42da-a324-77d23df6dc0c 32 fields · synced May 30, 2026
- EUDAMED 7eef2dbf-f2dd-4fdf-b998-60f8e1ef9aa9 61 fields · synced Jul 16, 2026
- EUDAMED 840d045d-bd97-4245-af2d-25df4ada6236 61 fields · synced Jul 25, 2026