Device Recall Fiber stripper

  • Model / Serial
    Model 0010-0751; All product manufactured from April 8, 2012 to April 8, 2015
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Stripper, 0.6mm Disposable EndoStat Fiber, || The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
  • Manufacturer
  • 1 Event

Manufacturer

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

14 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model 80-10001-003; All product manufactured from April 8, 2012 to April 8, 2015
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Fiber Stripper, 150¿m, Autoclavable; || The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
  • Manufacturer
  • Model / Serial
    Model 80-10001-001; All product manufactured from April 8, 2012 to April 8, 2015
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Tool, StripperW/BLD, 10S, Nonautoclavable; || The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
  • Manufacturer
  • Model / Serial
    Model 80-10001-002; All product manufactured from April 8, 2012 to April 8, 2015
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Tool, StripperW/BLD, 10S, Autoclavable; || The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
  • Manufacturer
  • Model / Serial
    Model 80-10002-001; All product manufactured from April 8, 2012 to April 8, 2015
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Tool, Stripper W/BLD, 12S, Nonautoclavable; || The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
  • Manufacturer
  • Model / Serial
    Model 80-10002-002; All product manufactured from April 8, 2012 to April 8, 2015
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Tool, Stripper W/BLD, 12S, Autoclavable; || The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
  • Manufacturer
9 more