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OneGuide Implant Driver
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref HOGFDSR50Ref HOGFDSM50Ref HOGFDSR57
Identity
- Trade Name
- OneGuide Implant Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- HOGFDSM50 EUDAMEDFDA UDIHOGFDSR50 EUDAMEDFDA UDIHOGFDSR57 EUDAMEDFDA UDIHOGFDSM35 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209369685 EUDAMEDFDA UDI08800209369692 EUDAMEDFDA UDI08800209369708 EUDAMEDFDA UDI08800209369678 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 Implant Driver by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
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 (7)
- FDA UDI d94eeec1-b2c6-4d59-8971-3a094c730ddb 32 fields · synced Oct 6, 2026
- FDA UDI 5863d4bf-6a49-4673-960d-05fd0fe8e4b0 32 fields · synced May 30, 2026
- FDA UDI 20d55e57-8f4e-48d8-95bf-26c866310e16 32 fields · synced May 30, 2026
- FDA UDI 26331949-136c-4711-833a-21aa67a7e84c 32 fields · synced May 30, 2026
- EUDAMED f2b6287a-5e7f-446a-a2a0-2980df6bacc0 61 fields · synced Jul 12, 2026
- EUDAMED fe5ad71c-dfe8-4874-a810-1f231ea5fd47 61 fields · synced Jul 16, 2026
- EUDAMED d4ae1895-05fc-47de-92e4-4dec3f124eec 61 fields · synced Aug 2, 2026