Osteon
by Conmed Corporation EUDAMEDGUDID
Active
Ref 5056-140, 5056-167, 5056-126, 5056-165, 5056-125, 5056-149, 5056-162, 5056-118, 5056-158, 5056-160, 5056-150, 5056-117, 5056-128, 5056-146, 00505614700
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-10845854005750 | Date8 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10845854005750 | Date24 Sep 2020 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- Generic Name
- Orthopaedic bur, single-use
- Device Name
- Orthopedic, Non-active, Handpiece BurPowered Surgical Instruments
- Model / Ref / Catalog
- 5056-140, 5056-167, 5056-126, 5056-165, 5056-125, 5056-149, 5056-162, 5056-118, 5056-158, 5056-160, 5056-150, 5056-117, 5056-128, 5056-146, 00505614700, 00505614900, 00505615000, 00505616700, 00505616500, 00505611700, 00505612500, 00505615800, 00505612600, 00505616000, 00505614600, 00505612800, 00505611800, 00505616200, 00505614000, 5056-147
- Primary DI / UDI-DI
- 10845854005750, 10845854005972, 10845854001820, 10845854000373, 10845854003619, 10845854001998, 10845854003893, 10845854008164, 10845854003909, 10845854000397, 10845854008256, 10845854000182, 10845854008997, 10845854005712, 10845854005897
- Basic UDI-DI
- B-10845854005750, B-10845854005972, B-10845854001820, B-10845854000373, B-10845854003619, B-10845854001998, B-10845854003893, B-10845854008164, B-10845854003909, B-10845854000397, B-10845854008256, B-10845854000182, B-10845854008997, B-10845854005712, B-10845854005897
- FDA Product Code
- GFF
- EMDN Code
- K030204, V9099
- GMDN Term
- Orthopaedic bur, single-use
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 878.4820
- Market of Registration
- Belgium
- Commercial Distribution
- In Commercial Distribution
- Size
- Length — 48 MillimeterOuter Diameter — 2.5 MillimeterOuter Diameter — 5 MillimeterOuter Diameter — 6 MillimeterLength — 38 MillimeterOuter Diameter — 0.7 MillimeterLength — 30 MillimeterOuter Diameter — 6.5 MillimeterOuter Diameter — 1 MillimeterOuter Diameter — 3 MillimeterOuter Diameter — 2 MillimeterOuter Diameter — 1.5 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000012663
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Conmed Corporation
Properties
Other properties (18)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No