Device Recall iovera

  • Modelo / Serial
    Serial Numbers: 100100, 100101, 100103
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US distribution including CA and ID.
  • Descripción del producto
    Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. || Product Usage: || The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Myoscience Inc, 1600 Seaport Blvd Suite 450, Redwood City CA 94063-5563
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Catalog numbers:STT0412-¿10 and STT0412-¿5;  Lot numbers : 1504021-¿01 and 1505008.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
  • Descripción del producto
    iovera 155 Smart Tip; || Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) || iovera Smart Tips are individually packaged in Tyvek PET pouches, which are || then packaged into 5 or 10 pack boxes and shipper boxes. || Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera device is not indicated for treatment of central nervous system tissue
  • Manufacturer