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OneGuide KS NoMount Driver
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OGNMDR57KRef OGNMDM35KRef OGNMDM50KRef OGNMDR50K
Identity
- Trade Name
- OneGuide KS NoMount Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OGNMDR57K EUDAMEDFDA UDIOGNMDM35K EUDAMEDFDA UDIOGNMDR50K EUDAMEDFDA UDIOGNMDM50K EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917098870 EUDAMEDFDA UDI08809917098801 EUDAMEDFDA UDI08809917098849 EUDAMEDFDA UDI08809917098818 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
Category: Surgical screwdriver, reusable
OneGuide KS NoMount Driver by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 (8)
- FDA UDI 1f207982-d172-421f-8d65-0cb1da46c9bc 32 fields · synced Aug 2, 2026
- FDA UDI 56e2a5d9-2b2c-41fd-a095-b0b23529cba4 32 fields · synced May 29, 2026
- FDA UDI 94fd63d7-5b00-478d-b682-34ef76c09dbd 32 fields · synced May 30, 2026
- FDA UDI 770d6b64-f3d9-4871-bae8-fae6a0d73228 32 fields · synced May 30, 2026
- EUDAMED 17f255c2-42df-4710-8308-391147d77efb 61 fields · synced Jun 20, 2026
- EUDAMED 2bf2ff9c-0190-464f-b650-ba4bf5b2287c 61 fields · synced Jul 9, 2026
- EUDAMED f2dde8f5-3f40-47cd-95aa-9ec5dce5369c 61 fields · synced Jul 13, 2026
- EUDAMED 1cc48d05-e5cb-4a24-ace4-80db81dfeb6e 61 fields · synced Aug 2, 2026