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Trephine Drill
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TD42Ref TTD62LRef TTD62SRef TTD42SRef TTD57LRef TTD42LRef TTD52SRef TTD52LRef TTD37L
Identity
- Trade Name
- Trephine Drill EUDAMEDFDA UDI
- Generic Name
- Bone trephine, reusable FDA UDI
- Device Name
- Surgical Drill System EUDAMED
- Model / Reference
- TD42 EUDAMEDFDA UDITTD62L EUDAMEDTTD62S EUDAMEDTTD42S EUDAMEDTTD57L EUDAMEDTTD42L EUDAMEDTTD52S EUDAMEDTTD52L EUDAMEDTTD37L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800000952017 EUDAMEDFDA UDI08800271285685 EUDAMED08800271285692 EUDAMED08800271285449 EUDAMED08800271285616 EUDAMED08800271285432 EUDAMED08800271285609 EUDAMED08800271285593 EUDAMED08800271285357 EUDAMED
- Basic UDI-DI
- 88000406DRILLH5 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone trephine, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 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
Trephine Drill by Osstem Implant Co., Ltd. — Class IIa — 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 | 88000406DRILLH5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (10)
- EUDAMED a70c753d-adbb-4ccf-8a0a-8bf7fe5883c7 61 fields · synced Jul 30, 2026
- FDA UDI 2e0dc9f7-fee6-4cdb-b55c-7952dec2a21c 32 fields · synced May 30, 2026
- EUDAMED 92da676d-1b36-4af0-bde5-6047712fe6d6 61 fields · synced Jul 9, 2026
- EUDAMED a26bf8ac-1dca-4e5b-a4bb-4184edee32ec 61 fields · synced Jul 9, 2026
- EUDAMED 8c3a501e-d88a-45c0-914f-ffd034c5cdeb 61 fields · synced Jul 10, 2026
- EUDAMED 838ae162-4355-4438-8fdb-c624e018cd6c 61 fields · synced Jul 11, 2026
- EUDAMED 9051359c-9639-4b6b-9666-0e40e5eeb4df 61 fields · synced Jul 14, 2026
- EUDAMED 7691c351-02f4-4ba0-8a1b-c8e3bd760a98 61 fields · synced Jul 20, 2026
- EUDAMED bf2d7b05-41f9-49cb-a014-d5a49661e523 61 fields · synced Jul 28, 2026
- EUDAMED 2c1695f0-64fc-4e81-936d-f2c7bffaed9a 61 fields · synced Jul 30, 2026