Renegade Fiber Braided Microcatheter

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    SATP

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  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Injections / Infusions / Transfusions / Dialysis
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 18-259 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 18-257 (Lot serial: >100 NUMBERS CONTACT MFG)
  • 제품 설명
    RENEGADE FIBER BRAIDED MICROCATHETER
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots:  11249879, 11542408, 11750295, 11966695, 12156146, 12228393, 12365497, 12491154,  11253574, 11546053, 11756331, 11988066, 12156147, 12228443, 12365604, 12509751,  11257185, 11552115, 11776786, 11996448, 12156183, 12228444, 12365605, 12509758,  11268801, 11554501, 11793108, 12001306, 12170507, 12248055, 12365613, 12509920,  11271408, 11559603, 11800162, 12001562, 12170508, 12248109, 12365614, 12527317,   11562655,  11274973, 11572313, 11806766, 12001567, 12170516, 12248121, 12385142, 12527760,  11296064, 11573180, 11819657, 12001568, 12175704, 12262088, 12385143, 12527763,  11301389, 11577242, 11825864, 12021328, 12175706, 12270709, 12385158, 12527769,  11303513, 11580376, 11836834, 12028753, 12175708, 12270714, 12385224, 12546795,   11840079,  11307943, 11586443, 11843094, 12039033, 12175710, 12270983, 12402095, 12546199,  11318319, 11587960, 11849818, 12049925, 12175711, 12279662, 12402111, 12546941,  11319596, 11602048, 11857667, 12061129, 12175713, 12292373, 12421265, 12546946,  11423369, 11623809, 11869009 12068930, 12175717, 12296121, 12421267, 12560791,   12073876,  11425310, 11627605, 11876193, 12089556, 12175719, 12296833, 12421271, 12560192  11425314, 11631734, 11880345, 12104631, 12175724, 12297455, 12421274, 12578834  11429065, 11638177, 11884227, 12104678, 12194075, 12311446, 12439946, 12578835  11429069, 11649446, 11891449, 12108064, 12194077, 12311459, 12439951, 12578864   12194829,  11432583, 11656601, 11891458, 12120518, 12194831, 12311520, 12439954, 12614498,  11432584, 11678955, 11895180, 12120528, 12214586, 12326062, 12439958, 12634309,  11441965, 11682874, 11895183, 12123141, 12214589, 12330440, 12458414, 12634310,  11444027, 11695922, 11925162, 12133525, 12214592, 12330441, 12458475, 12634315,   12330443,  11445708, 11703970, 11927490, 12142142, 12214602, 12330465, 12458416, 12659579,  11461698, 11706368, 11933896, 12142150, 12214604, 12330476, 12458543, 12660000,  11469070, 11710717, 11941913, 12148683, 12214616, 12330511, 12458548,  11481564, 11714291, 11948975, 12148684, 12228116, 12348609, 12466721,  11534917, 11721375, 11959863, 12148687, 12228366, 12365495, 12466123,
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution Worldwide, including throughout the US.
  • 제품 설명
    Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; || Model Numbers: 18257, 18259; Product is distributed by || Boston Scientific Corporation, Natick, MA; || Product is manufactured by Boston Scientific Corporation, Cork, Ireland
  • Manufacturer
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