Identity
- Trade Name
- BONE PROFILER EUDAMEDFDA UDI
- Generic Name
- Paranasal sinus trephine FDA UDI
- Device Name
- Surgical Drill System EUDAMEDSurgical Instrument System EUDAMED
- Model / Reference
- GSBP45 EUDAMEDFDA UDIHGSBGS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209358597 EUDAMEDFDA UDI08800209367520 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406DRILLH5 EUDAMED88000406CLASSIBS25V EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Paranasal sinus trephine FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA 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
Bone Profiler 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 (4)
- EUDAMED 620ff13c-643b-418f-94df-561a5b830d78 61 fields · synced Jul 27, 2026
- FDA UDI 4cf95cec-bc59-4ed4-aaae-c039204b41d0 32 fields · synced May 27, 2026
- FDA UDI 898b7134-6130-4d85-b8b0-cdd027679793 32 fields · synced May 30, 2026
- EUDAMED 51a3036c-0372-4174-bd69-14a613fd804a 61 fields · synced Jul 27, 2026