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Bur - 2.38mm, Fluted Ball Gold, 120mm X 6.0mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref C12-06031
by Zethon Ltd
Identity
- Trade Name
- Zethon FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- BUR - 2.38MM, FLUTED BALL GOLD, 120MM X 6.0MM EUDAMEDFDA UDI
- Model / Reference
- C12-06031 EUDAMEDFDA UDI
- Description
- BUR - 2.38MM, FLUTED BALL GOLD, 120MM X 6.0MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05059358054086 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05059358054086 EUDAMED
- 510(k) Number
- K233958 FDA UDI
- FDA Product Code
- HBE FDA UDI
- EMDN Code
- Z12100985 INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES EUDAMED
- GMDN Term
- Orthopaedic bur, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4310 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Bur - 2.38mm, Fluted Ball Gold, 120mm X 6.0mm by Zethon Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-05059358054086 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Zethon Ltd
- EUDAMED SRN
- GB-MF-000014309
- Authorised Representative
- De Soutter Medical Limited NL-AR-000000438
Sources (2)
- EUDAMED 613f8ac6-6afe-40f9-af06-2633f04e8a84 61 fields · synced Jun 18, 2026
- FDA UDI af22f3d9-9472-41d5-9200-c3479b4b85a3 34 fields · synced May 25, 2026