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TS Implant Driver
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref GSMFDERef GSRFDSRef GSRFDL
Identity
- Trade Name
- TS Implant Driver EUDAMEDFDA UDIImplant Driver FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- GSMFDE EUDAMEDFDA UDIGSRFDS EUDAMEDFDA UDIGSRFDL EUDAMEDFDA UDIGSRFDE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209394540 EUDAMEDFDA UDI08809892347925 EUDAMEDFDA UDI08809892347918 EUDAMEDFDA UDI08800209394717 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
TS 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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- 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
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 8a44037f-3008-43d6-a2fc-0d528d75559d 32 fields · synced Jul 23, 2026
- FDA UDI 66d7c6e7-5c6a-4777-8d0c-9ee8eaf3807a 32 fields · synced May 30, 2026
- FDA UDI a1a7aa06-8ae9-42a2-92b9-cf09e6cfe814 32 fields · synced May 30, 2026
- FDA UDI 6f417de1-e4e9-4692-98a6-aa63da2175a4 32 fields · synced May 30, 2026
- EUDAMED ecbbb824-b36f-453a-9ea9-d787d0dfc341 61 fields · synced Jul 12, 2026
- EUDAMED cb17150d-cba0-4234-9f34-289d46c3ac58 61 fields · synced Jul 12, 2026
- EUDAMED c0aaf4a7-6f2b-443f-beef-0ede88806caa 61 fields · synced Jul 23, 2026