Skip to content

DANmed LEM-603-450

by STERIS Deutschland GmbH

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04251351160882 UDI-DI Date31 Mar 2020ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0062-2019 FDA Class III initiated 6 Aug 2018

    The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
DANmed
Generic Name
Endoscopic electrosurgical electrode, monopolar, reusable
Model / Ref / Catalog
LEM-603-450
Description
LAP- Electrode, monop., Ø5mm, l=450mm Spatula, solid model
Primary DI / UDI-DI
04251351160882
510(k) Number
FDA Product Code
GEI
GMDN Term
Endoscopic electrosurgical electrode, monopolar, reusable
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from STERIS Deutschland GmbH

See all devices from STERIS Deutschland GmbH →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No