Universal Plus
by Conmed Corporation United States EUDAMEDGUDID
Ref 60-6010-003, 60-5274-027, 60-6010-000, 60-6002-302, 60-5272-132, 60-6002-309, 60-6010-005, 60-5274-032, 60-5272-032
Product code GCJEMDN K02030109
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-30653405011723 | Date14 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number30653405011723 | Date24 Sep 2016 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Recalls
-
- Terminated Z-1250-2022
Potential for the tip of the electrode to detach during use.
Specification
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-useEndoscopic electrosurgical electrode, monopolar, single-useSurgical irrigation/aspiration cannula, non-illuminating, reusable
- Device Name
- Non-orthopedic, Active, Instrument, Electrosurgical, Suction/Irrigation HandpieceNon-orthopedic, Active, Instrument, Electrosurgical, Suction/Irrigation Electrode, DisposableNon-orthopedic, Non-active, Instrument, Suction/Irrigation, Handpiece and Tubing, Universal
- Model / Ref / Catalog
- 60-6010-003, 60-5274-027, 60-6010-000, 60-6002-302, 60-5272-132, 60-6002-309, 60-6010-005, 60-5274-032, 60-5272-032
- Primary DI / UDI-DI
- 30653405011723, 30653405010696, 30653405011686, 30653405011518, 30653405010627, 30653405040723, 30653405011730, 30653405010702, 30653405010580
- Basic UDI-DI
- B-30653405011723, B-30653405010696, B-30653405011686, B-30653405011518, B-30653405010627, B-30653405040723, B-30653405011730, B-30653405010702, B-30653405010580
- FDA Product Code
- GCJ, GEI
- EMDN Code
- K02030109, K0201010302, L030101
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-useEndoscopic electrosurgical electrode, monopolar, single-useSurgical irrigation/aspiration cannula, non-illuminating, reusable
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMEDClass II GUDID
- Regulation Number
- 876.1500, 878.4400
- Market of Registration
- Belgium
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Ethylene OxideMoist Heat or Steam Sterilization
- Size
- Outer Diameter — 5 MillimeterLength — 32 CentimeterLength — 44 CentimeterOuter Diameter — 10 MillimeterLength — 27 Centimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000012663
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Conmed Corporation
Properties & raw data
Show properties, registry sources and raw records
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
Sources (18)
- EUDAMED 0a0567d6-b4a4-4df9-9ec5-962cc810d40d
- EUDAMED 30653405010696|B-30653405010696
- EUDAMED 30653405011686|B-30653405011686
- EUDAMED 30653405011518|B-30653405011518
- EUDAMED 30653405010627|B-30653405010627
- EUDAMED 30653405040723|B-30653405040723
- EUDAMED 30653405011730|B-30653405011730
- EUDAMED 30653405010702|B-30653405010702
- EUDAMED 30653405010580|B-30653405010580
- FDA UDI fd0b859b-faf5-490f-89d9-ef5c6c2082cd
- FDA UDI 613ce6f2-9493-4c85-b50f-b2720cd533c2
- FDA UDI 1ad68fda-c376-4605-8cec-81e19fb8126b
- FDA UDI fa1886f2-8939-4e23-86b3-6929fee1f568
- FDA UDI fdb1144d-6216-4596-9012-6e7847de03d7
- FDA UDI 6069954a-4b97-4e37-a0c8-929546c59b33
- FDA UDI 1cbe6dfc-f423-4976-b920-2647816cd625
- FDA UDI e858ec10-a165-4245-860e-ab65afdb033d
- FDA UDI 298773ee-6ca8-4a8f-8ee8-9f50c8d9db53