Device Recall Fiber Cleaver

  • Modèle / numéro de série
    Model 80-10007-001; All product manufactured from April 8, 2012 to April 8, 2015
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Israel, Poland, United Kingdom, Chile, Italy, Portugal, United States, Colombia, Korea, Qatar, Uruguay, Costa Rica, Lebanon, Romania, Finland, Malaysia and Saudi Arabia.
  • Description du dispositif
    1X1 Cleaving Tiles; || The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    American Medical Systems Innovation Center - Silicon Valley, 3070 Orchard Dr, San Jose CA 95134-2011
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Model 0010-0760; All product manufactured from April 8, 2012 to April 8, 2015
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Israel, Poland, United Kingdom, Chile, Italy, Portugal, United States, Colombia, Korea, Qatar, Uruguay, Costa Rica, Lebanon, Romania, Finland, Malaysia and Saudi Arabia.
  • Description du dispositif
    Fiber Cleaver; || Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) || The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.
  • Manufacturer