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by Conmed Corporation United States EUDAMEDGUDID
Ref 2-1018
Product code GEIEMDN L180602
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-30653405059381 | Date13 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number30653405059381 | Date24 Sep 2016 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Recalls
-
- Terminated Z-0091-2007
- Terminated Z-0085-2007
- Terminated Z-0086-2007
- Terminated Z-0088-2007
- Terminated Z-0083-2007
- Terminated Z-0092-2007
- Terminated Z-0089-2007
- Terminated Z-0090-2007
- Terminated Z-0084-2007
- Terminated Z-0087-2007
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
-
- Terminated Z-1434-06
- Terminated Z-1433-06
Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.
Specification
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, reusable
- Device Name
- Non-orthopedic, Active, Instrument, Electrosurgical, Handle and Interchangeable Instrument
- Model / Ref / Catalog
- 2-1018
- Primary DI / UDI-DI
- 30653405059381
- Basic UDI-DI
- B-30653405059381
- 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 EUDAMEDClass 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 MillimeterLength — 33 Centimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | 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 (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 08cece90-9156-4189-affe-ed19e297af7f
- FDA UDI 5ed28396-c370-48a8-8751-7254d4b02b8e