OneGuide TS Implant Driver (Stopper Type)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- OneGuide TS Implant Driver (Stopper Type) EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OGFDSR57 EUDAMEDFDA UDIOGFDSR50 EUDAMEDFDA UDIOGFDSM50 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917109217 EUDAMEDFDA UDI08809917109200 EUDAMEDFDA UDI08809917109194 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical screwdriver, reusable
OneGuide TS Implant Driver (Stopper Type) 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.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (6)
- FDA UDI 825be27b-f43f-486e-9266-36adb663b87c 32 fields · synced Jul 10, 2026
- FDA UDI 917122f9-51c3-4577-8a31-cc8a64dfd4b5 32 fields · synced May 30, 2026
- FDA UDI 6d496e45-4b2e-4464-aa64-75008c44cc93 32 fields · synced May 30, 2026
- EUDAMED d755b640-3685-446b-a75b-8d2b46fa1d97 61 fields · synced Jul 8, 2026
- EUDAMED 446b798c-f285-405f-ba76-af2fc0db5f99 61 fields · synced Jul 9, 2026
- EUDAMED fedc0652-6488-445c-bb12-be624ccb1d78 61 fields · synced Jul 10, 2026