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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

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-30653405011723 Basic UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30653405011723 UDI-DIDate24 Sep 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

1 recall · FDA

    • Terminated Z-1250-2022 FDA Class II initiated 3 May 2022 via K952204, on the same 510(k)

    Potential for the tip of the electrode to detach during use.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Endoscopic electrosurgical electrode, monopolar, single-use
Surgical irrigation/aspiration cannula, non-illuminating, reusable
Device Name
Non-orthopedic, Active, Instrument, Electrosurgical, Suction/Irrigation Handpiece
Non-orthopedic, Active, Instrument, Electrosurgical, Suction/Irrigation Electrode, Disposable
Non-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-use
Endoscopic electrosurgical electrode, monopolar, single-use
Surgical irrigation/aspiration cannula, non-illuminating, reusable
Device Class
Class IIb EUDAMED
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500, 878.4400
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Moist Heat or Steam Sterilization
Size
Outer Diameter — 5 Millimeter
Length — 32 Centimeter
Length — 44 Centimeter
Outer Diameter — 10 Millimeter
Length — 27 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile YesEUDAMEDGUDIDNoEUDAMEDGUDID
  • Single Use YesGUDIDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date YesGUDIDNoGUDID
  • Manufacturing Date NoGUDIDYesGUDID
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 61 fields · synced 22 Oct 2026
  • EUDAMED 30653405010696|B-30653405010696 61 fields · synced 17 May 2026
  • EUDAMED 30653405011686|B-30653405011686 61 fields · synced 17 May 2026
  • EUDAMED 30653405011518|B-30653405011518 61 fields · synced 17 May 2026
  • EUDAMED 30653405010627|B-30653405010627 61 fields · synced 17 May 2026
  • EUDAMED 30653405040723|B-30653405040723 61 fields · synced 17 May 2026
  • EUDAMED 30653405011730|B-30653405011730 61 fields · synced 18 May 2026
  • EUDAMED 30653405010702|B-30653405010702 61 fields · synced 18 May 2026
  • EUDAMED 30653405010580|B-30653405010580 61 fields · synced 18 May 2026
  • FDA UDI fd0b859b-faf5-490f-89d9-ef5c6c2082cd 36 fields · synced 29 May 2026
  • FDA UDI 613ce6f2-9493-4c85-b50f-b2720cd533c2 38 fields · synced 29 May 2026
  • FDA UDI 1ad68fda-c376-4605-8cec-81e19fb8126b 36 fields · synced 30 May 2026
  • FDA UDI fa1886f2-8939-4e23-86b3-6929fee1f568 38 fields · synced 30 May 2026
  • FDA UDI fdb1144d-6216-4596-9012-6e7847de03d7 38 fields · synced 30 May 2026
  • FDA UDI 6069954a-4b97-4e37-a0c8-929546c59b33 38 fields · synced 30 May 2026
  • FDA UDI 1cbe6dfc-f423-4976-b920-2647816cd625 38 fields · synced 30 May 2026
  • FDA UDI e858ec10-a165-4245-860e-ab65afdb033d 36 fields · synced 30 May 2026
  • FDA UDI 298773ee-6ca8-4a8f-8ee8-9f50c8d9db53 38 fields · synced 30 May 2026