Skip to content

DetchaTip

by Conmed Corporation United States EUDAMEDGUDID

Ref 2-1004

Product code GEIEMDN L180602

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-30653405059282 Basic UDI-DIDate13 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30653405059282 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

12 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-0091-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0085-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0086-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0088-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0083-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0092-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0089-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0090-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0084-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0087-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006

    The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.

  • 2 recalls, same reason

    • Terminated Z-1434-06 FDA Unclassified (pre-2012) initiated 27 Mar 2006
    • Terminated Z-1433-06 FDA Unclassified (pre-2012) initiated 27 Mar 2006

    Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Generic Name
Endoscopic electrosurgical electrode, monopolar, reusable
Device Name
Non-orthopedic, Active, Instrument, Electrosurgical, Handle and Interchangeable Instrument
Model / Ref / Catalog
2-1004
Primary DI / UDI-DI
30653405059282
Basic UDI-DI
B-30653405059282
510(k) Number
FDA Product Code
GEI
EMDN Code
L180602 Endoscopic electrosurgery electrodes, reusable
GMDN Term
Endoscopic electrosurgical electrode, monopolar, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 5 Millimeter
Length — 33 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
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
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (20)
  • Single Use: No
  • 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
  • Manufacturing Date: No

Sources (2)

  • EUDAMED fd0cab29-7d48-43dc-92c9-91b9db485ccb 61 fields · synced 23 Oct 2026
  • FDA UDI 38c3b0d8-43c6-4ae0-9d55-b617cc2112d3 38 fields · synced 30 May 2026