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Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System
EUDAMEDFDA UDIClass I (EU MDR)
Ref NDB-01
Identity
- Trade Name
- Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System EUDAMEDNeuro Plating System FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Surgical Instrument EUDAMEDDrill Bit FDA UDI
- Model / Reference
- NDB-01 EUDAMEDFDA UDI
- Description
- Drill Bit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809399745897 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809399745897 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L1104 BITS FOR NEUROSURGERY DRILLS, REUSABLE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Bulgaria 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System by OSTEONIC CO., Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809399745897 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSTEONIC Co., Ltd.
- EUDAMED SRN
- KR-MF-000008969
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d2455b0c-74d1-45a0-b031-169ede9e022a 61 fields · synced Jul 27, 2026
- FDA UDI a7ba0a04-ea46-40dc-b20e-7b31796ec521 33 fields · synced May 30, 2026