Device Recall AR1000 Qoustic Qurette"

  • Modelo / Serial
    0001 and 0002
  • Clasificación del producto
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - US (nationwide) and the states of AL, CA, ID, IN, IA, MI, MN, MS, NJ, NM, OH, PA. SC, TX, UT, VA, WI. including the country of SAUDI ARABIA.
  • Descripción del producto
    Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. || Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. || Product Usage: || The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Arobella Medical, LLC, 5929 Baker Rd Ste 470, Minnetonka MN 55345-4770
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA