Device Recall Stapler

  • Model / Serial
    OEM Catalog number 6206.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Product Description
    Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 6206; || EXP (repackager), Covidien (OEM) || Implantable Staple
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    EXP Pharmaceutical Services Corp, 48021Warm Springs Boulevard, Fremont CA 94539
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

22 devices with a similar name

Learn more about the data here

  • Model / Serial
    OEM Catalog number 173054.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Product Description
    Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 173054; || EXP (repackager), Tyco (OEM) || Laparoscope, General & Plastic Surgery
  • Manufacturer
  • Model / Serial
    All
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.
  • Product Description
    STAPLER 45, IS4000, model number 470298 || Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection || and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
  • Manufacturer
  • Model / Serial
    All
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.
  • Product Description
    STAPLER 30, IS4000, model number 470430; || Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of || anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
  • Manufacturer
  • Model / Serial
    All model 470298
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,
  • Product Description
    STAPLER,IS4000; Model number 470298; || General and Plastic Surgery: || The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
  • Manufacturer
  • Model / Serial
    All model 470430
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,
  • Product Description
    STAPLER 30,IS4000; Model number 470430; || General and Plastic Surgery: || The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult || and pediatric use. The device can be used with staple line or tissue buttressing material.
  • Manufacturer
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