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OneGuide TS Implant Driver
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OGFDM50Ref OGFDR50
Identity
- Trade Name
- OneGuide TS Implant Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OGFDR50 EUDAMEDFDA UDIOGFDM50 EUDAMEDFDA UDIHOGIDHSR57 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917109163 EUDAMEDFDA UDI08809917109125 EUDAMEDFDA UDI08800271233990 FDA 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
Category: Surgical screwdriver, reusable
OneGuide TS Implant Driver by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (5)
- FDA UDI 4c557886-86fc-4322-8eb6-74f63f4433f2 32 fields · synced Jul 15, 2026
- FDA UDI 9760f46a-685d-426c-9f1d-fc87959b9b26 32 fields · synced May 30, 2026
- FDA UDI 8eee8bfb-6014-4d5a-b90f-dde9e7114156 32 fields · synced May 30, 2026
- EUDAMED 5515ab1f-aebb-4b6e-b50d-1a4f6b4905b8 61 fields · synced Jul 9, 2026
- EUDAMED 73a6ad42-b14e-4f22-a608-426889d4f87b 61 fields · synced Jul 15, 2026