Device Recall iovera Smart Tip

  • Model / Serial
    Catalog numbers:STT0412-¿10 and STT0412-¿5;  Lot numbers : 1504021-¿01 and 1505008.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Myoscience Inc, 46400 Fremont Blvd, Fremont CA 94538-6469
  • Manufacturer Parent Company (2017)
  • Source
    USFDA