Resolution II

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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

6 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    Medical instruments for use in humans
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    Medical instruments for use in humans
  • Manufacturer
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Implant - surgery
  • Manufacturer
  • Modelo / Serial
    Catalog M00522500: Lot 1ML1013103, ML00000004, ML00000129, Catalog M00522501: Lot 1ML1013104, ML00000071, ML00000148, Catalog M00522502: Lot 1ML1013102, ML00000042, ML00000131, Catalog No. M00522501: Lot 1ML1011201, 1ML1013101, 1ML1020202, 1ML1021402, 1ML1022202, ML1022213,ML00000013, ML00000019, L00000058,ML00000073, ML00000098, ML00000120,  Catalog No. M00522511: Lot 1ML1010605, 1ML1012602, 1ML1013105, 1ML1020203, 1ML1021403, 1ML1022203,1ML1022214, ML00000014, ML00000020,ML00000043, ML00000059, ML00000074,ML00000099, ML00000119, Catalog No. M00522512: Lot 1ML1011905, 1ML1020201, 1ML1021401, 1ML1022201, 1ML1022215, ML00000018,ML00000032, ML00000040, ML00000072,ML00000097, ML00000135, and ML00000137
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - including USA (nationwide)
  • Descripción del producto
    The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system. || Endoscopic Clipping Device, Hemorrhoidal Ligator. The device is used for clip placement within the GI tract for hemostatis ( mucosal defects, bleeding ulcer, arteries, polyps); endoscopic marking; and anchoring to affix jejunal feeding tubes to the wall of the small bowel, as a supplementary method for closure of GI tract luminal perforation <20 mm that can be treated conservatively.
  • Manufacturer
Uno más