Device Recall Ellex Integre Duo

  • Model / Serial
    Integre Duo LP1RG-S P/N 3040000  (serial # /system #): 31418 / ID1057
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including states of WI, PA, CO, CA, NC, NY, SC, MD, and MS, and countries of Canada and Brazil.
  • Product Description
    Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. (The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient clinic, or a retinal specialist's office. )
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ellex USA, 7138 Shady Oak Road, Eden Prairie MN 55344
  • Source
    USFDA