Archer Super Stiff Guidewire

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
    SATP

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  • 모델명 / 제조번호(시리얼번호)
    Model: ARCSJ200WLot: GFWC1124; GFWC1506; GFWC2138; GFWC2652; GFWC2653; GFWD0353; GFWD0881; GFWD0882; GFWD2048; GFWD2049; GFWD2050; GFWD2051; GFWD2052; GFWE0743; GFWE0744; GFWE0745; GFWE0746; GFWE0747; GFWE3710; GFWE4272; GFWE4273; GFWE4274; GFWE4275; GFWF0143; GFWF0144; GFWF0147; GFWF0148; GFWF0149; GFWG0428; GFWG0429; GFWG0430; GFWG0431; GFWG0432; GFWG0433; GFWG0434; GFWH0333; GFWH0334; GFWH0335; GFWH0336; GFWH0337; GFWH0338; GFWI0190; GFWI0191; GFWI0192; GFWI0193; GFWI0194; GFWI0195; GFWJ0027; GFWJ0028; GFWJ0029; GFWJ2454; GFWJ2455; GFWJ2456; GFWJ2457; GFWJ2458; GFWK1910; GFWK1911; GFWL0370; GFWL2571; GFWL2572; GFXA0224;Model: ARCSJ260WLot: GFWC1501; GFWC1502; GFWC1503; GFWD0883; GFWD0884; GFWD3256; GFWE0752; GFWE0753; GFWE3711; GFWF0145; GFWF0150; GFWG0425; GFWG0426; GFWG0427; GFWH0344; GFWH0345; GFWI0201; GFWI0202; GFWI0203; GFWJ0418; GFWJ0419; GFWJ0420; GFWJ2461; GFWJ2462; GFWJ2464; GFWJ2465; GFWL0368; GFWL0369; GFWL0415; GFWL0416; GFXA0219; GFXA0220; GFXA0221; GFXA0222;Model: ARCDJ260WLot: GFWC1507; GFWC1508; GFWD0885; GFWE0750; GFWE0751; GFWF0142; GFWF0146; GFWG0423; GFWG0424; GFWH0331; GFWH0332; GFWI0186; GFWI0187; GFWI0188; GFWJ2449; GFWJ2450; GFWJ2451; GFWJ2452; GFWK1844
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot number GFWA0387
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.
  • 제품 설명
    Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. || Intended to facilitate catheter placement and exchange during procedures in the aorta.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer