Octopus Nuvo Tissue Stabilizer

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    BAM

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  • 모델명 / 제조번호(시리얼번호)
    TSMICS1 | see letter
  • 제품 설명
    MD: Patient positioning vacuum pad
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot #: 201002P030, 2010030795, 2010032195, 2010032196, 2010032690, 2010033377, 2010040102, 2010040103, 2010040673, 2010041001, 2010041500, 2010061786, 2010062722, 2010071111, 2010081105, 2010081987.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    within the US to: AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI and Washington D.C. OUS to include: Belgium, Canada, Germany, Italy, Poland, Switzerland, United Kingdom.
  • 제품 설명
    Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable tissue stabilization system consisting of a rigid shaft, detachable tissue stabilizer headlink and a flexible articulating arm. The device is assembled within the thoracic cavity. Sterilized using ethylene oxide, non pyrogenic, disposable, single use only. || The product is intended to stabilize and minimize the motion of selected areas of the beating heart during minimally invasive cardiac surgery procedures under direct visualization through a thoracotomy.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Octopus Nuvo Tissue Stabilizer Model TSMICS1
  • Manufacturer