Core Dynamics
by Conmed Corporation EUDAMEDGUDID
Active
Ref CD8450, CD8190, CD849, CD856, CD8300, CD860
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-10653405046301 | Date8 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10653405046301 | Date24 Sep 2016 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- Surgical irrigation/aspiration cannula, non-illuminating, reusableSurgical irrigation/aspiration tubing setSurgical irrigation/aspiration handpiece control valve
- Device Name
- Non-orthopedic, Non-active, Instrument, Suction/Irrigation, Handpiece and Tubing, Core TrumpetNon-orthopedic, Non-active, Instrument, Suction/Irrigation, Cannula, Core
- Model / Ref / Catalog
- CD8450, CD8190, CD849, CD856, CD8300, CD860
- Primary DI / UDI-DI
- 10653405046301, 10653405046219, 10653405046288, 20653405046339, 10653405046226, 10653405046363
- Basic UDI-DI
- B-10653405046301, B-10653405046219, B-10653405046288, B-20653405046339, B-10653405046226, B-10653405046363
- FDA Product Code
- GCJ, GBW
- EMDN Code
- A03040299, L030101
- GMDN Term
- Surgical irrigation/aspiration cannula, non-illuminating, reusableSurgical irrigation/aspiration tubing setSurgical irrigation/aspiration handpiece control valve
- Device Class
- Class IIa EUDAMEDClass II GUDIDClass I GUDID
- Regulation Number
- 876.1500, 878.4200
- Market of Registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam SterilizationEthylene Oxide
- Size
- Outer Diameter — 10 MillimeterLength — 32 CentimeterLength — 45 CentimeterOuter Diameter — 5 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II 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
- Premarket Exempt: No
- Serial Number: No