Devices

Suturing Device

Fabricante

Boston Scientific Corporation
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • 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
    NZMMDSA

Dispositivo con un nombre similar

Más información acerca de la data acá

ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew
  • Modelo / Serial
    Product Order #ESD-5:  Lot #1519202, Vendor Exp. 05/2002 * Label Exp. 08/2006, Lot #1520620, Vendor Exp. 05/2002 * Label Exp. 08/2006, Lot #1521208, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1521209, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1521210, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1521211, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1537952, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1540901, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1540902, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1541688, Vendor Exp 06/2003 * Label Exp. 09/2006, Lot #1542196, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1545823, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1546030, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1548352, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1550759, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1551793, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1553535, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1577921, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1577922, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1577923, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1581400, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1582964, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584872, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584573, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584928, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1585415, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1593074, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1595660, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595661, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595662, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595663, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1695664, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1695665, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595666, Vendor Exp. 09/2003 * Label Exp. 03/2007.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Brazil, Canada, Hong Kong, Ireland & Pakistan
  • Descripción del producto
    ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew ¿ Right Device: Flexible TI ¿ Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI ¿ Knot Quickload Units (2) * Disposable ¿ Single Use Only * Manufactured by: LSI Solutions * Sterile/EO * Rx Only * Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
  • Manufacturer
    Wilson-Cook Medical Inc