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Angled Torque Driver SET
EUDAMEDFDA UDIClass I (EU MDR)
Ref ATD12S3SRef ATD12L3SRef ATD12E3SRef HATD12L3S
Identity
- Trade Name
- Angled Torque Driver SET EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- ATD12S3S EUDAMEDFDA UDIATD12L3S EUDAMEDFDA UDIHATD12L3S EUDAMEDFDA UDIATD12E3S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800000965390 EUDAMEDFDA UDI08800209393154 EUDAMEDFDA UDI08800209366141 EUDAMEDFDA UDI08800209393130 EUDAMED
- 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
Angled Torque Driver SET by Osstem Implant Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000406CLASSIBS25V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
- EUDAMED SRN
- KR-MF-000020006
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (7)
- EUDAMED 86db2cdf-d87e-43a0-8455-f28c95edf326 61 fields · synced Jul 22, 2026
- FDA UDI d5f1822e-8bcc-4b29-baac-f10f3ff6b938 32 fields · synced May 29, 2026
- FDA UDI f29eaf7f-e864-4808-9df6-8d7614047a8f 32 fields · synced May 30, 2026
- FDA UDI f566191a-1a1e-4f80-9fb3-ba07f18966ec 32 fields · synced May 30, 2026
- EUDAMED 9f716a4e-f628-4fb6-869b-4c2d5f11bada 61 fields · synced Jul 8, 2026
- EUDAMED 4f982838-a2d5-488d-a3fd-0b571e85d588 61 fields · synced Jul 8, 2026
- EUDAMED 25134643-be55-4663-840f-f0c4fd2abe33 61 fields · synced Jul 22, 2026