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OneGuide TS NoMount Driver
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OGNMDM50Ref OGNMDR57Ref OGNMDR50
Identity
- Trade Name
- OneGuide TS NoMount Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OGNMDR57 EUDAMEDFDA UDIOGNMDM50 EUDAMEDFDA UDIOGNMDR50 EUDAMEDFDA UDIHOGNMDM57 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917108487 EUDAMEDFDA UDI08809917108654 EUDAMEDFDA UDI08809917109255 EUDAMEDFDA UDI08800271234010 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 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 (7)
- FDA UDI f217ec3e-5741-4448-b31d-bb3c90ffd5eb 32 fields · synced Jul 29, 2026
- FDA UDI 9958e2c9-97c5-44ba-b1a2-ebc4ba8ce0cc 32 fields · synced May 30, 2026
- FDA UDI 88884d8e-9c55-4c33-a3d6-0fa5a090a3f7 32 fields · synced May 30, 2026
- FDA UDI cd8478dd-0b22-4a35-afca-c93cd363291a 32 fields · synced May 30, 2026
- EUDAMED daa85746-b11c-4c87-9bb7-3cce4728d639 61 fields · synced Jul 22, 2026
- EUDAMED d6fa891d-a7e5-4559-8e7e-a88183cf755c 61 fields · synced Jul 24, 2026
- EUDAMED 79565f13-56d6-43ce-ac96-4ab8d28c9bcc 61 fields · synced Jul 29, 2026