Device Recall OASIS Medical Vidaurri LASIK Flap Irrigator

  • Model / Serial
    Product Specification 8065403604 Lot D0304S Lot D0405A Y Lot D05058H
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland
  • Product Description
    OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is || placed into a Tyvek pouch, heat-sealed and sterilized. After sterilization, 10 pouches are loaded into a carton, the carton is labeled and heat-shrink wrapped.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Oasis Medical Inc, 512 S Vermont Ave, Glendora CA 91741-6205
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product Specification 4036V Lot D1201AD Lot D0702A Y Lot D0802J Lot D09028 Lot D0103V Lot D0303S Lot D1203AH Lot D0104AC Lot D0304AQ Lot D0504AG Lot D0105AV Lot D0205J Lot D0305AH Lot D03058D Lot D0605AE Lot D0705Y Lot D0805A8
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland
  • Product Description
    OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2'' stainless steel cannula with two 25g x 9/16'' tip extensions. There are eight .25mm ports (four per tip).
  • Manufacturer
  • Model / Serial
    Product Specification MK-036V Lot D0305Y
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland
  • Product Description
    OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification MK-036V, LASIK Flap Irrigator (Vidaurri) || The MK-03V cannula is placed into a vacuum formed plastic tray and a blank Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and placed into a polybag. The polybag is sealed and labeled. Typically there are 100 pouches per polybag.
  • Manufacturer
  • Model / Serial
    Product Specification 8-4036V-NS Lot D060488 Lot D0804T Lot D0904A Lot D1004AV Lot D12048X
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland
  • Product Description
    OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification B-4036V-NS, LASIK Flap Irrigator (Vidaurri) || The -B4036V-NS cannula is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a polybag. The polybag is sealed and labeled. Typically there are 100 trays per polybag.
  • Manufacturer