LINX Reflux Management System

  • Modelo / Serial
    a. Product Code LXM-13, Part No. 4549-13, GTIN 00855106005394;  b. Product Code LXM-14, Part No. 4549-14, GTIN 00855106005400;  c. Product Code LXM-15, Part No. 4549-15, GTIN 00855106005417;  d. Product Code LXM-16, Part No. 4549-16, GTIN 00855106005424;     Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) in states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and in countries of: Austria, France, Germany, Italy, Scotland, Spain, Switzerland, United Kingdom.
  • Descripción del producto
    LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: || a. Product Code LXM-13; || b. Product Code LXM-14; || c. Product Code LXM-15; || d. Product Code LXM-16; || Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Torax Medical, Inc., 4188 Lexington Ave N, Shoreview MN 55126-6106
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

9 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
  • Descripción del producto
    md
  • Manufacturer
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - special implants
  • Manufacturer
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - special implants
  • Manufacturer
  • Modelo / Serial
    a. Product Code LS-12, Part No. 2170-6, GTIN 00855106005011;  b. Product Code LS-13, Part No. 2170-7, GTIN 00855106005028;  c. Product Code LS-14, Part No. 2170-8, GTIN 00855106005035;  d. Product Code LS-15, Part No. 2170-9, GTIN 00855106005042;  e. Product Code LS-16, Part No. 2170-10, GTIN 00855106005059;  f. Product Code LS-17, Part No. 2170-11, GTIN 00855106005066;   Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) in states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and in countries of: Austria, France, Germany, Italy, Scotland, Spain, Switzerland, United Kingdom.
  • Descripción del producto
    LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: || a. Product Code LS-12; || b. Product Code LS-13; || c. Product Code LS-14; || d. Product Code LS-15; || e. Product Code LS-16; || f. Product Code LS-17; || Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
  • Manufacturer
  • Modelo / Serial
    a. Product Code LXC-12, Part No. 3718-12, GTIN 00855106005134;  b. Product Code LXC-13, Part No. 3718-13, GTIN 00855106005141;  c. Product Code LXC-14, Part No. 3718-14, GTIN 00855106005158;  d. Product Code LXC-15, Part No. 3718-15, GTIN 00855106005165;  e. Product Code LXC-16, Part No. 3718-16, GTIN 00855106005172;  f. Product Code LXC-17, Part No. 3718-17, GTIN 00855106005189;   Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) in states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and in countries of: Austria, France, Germany, Italy, Scotland, Spain, Switzerland, United Kingdom.
  • Descripción del producto
    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: || a. Product Code LXC-12; || b. Product Code LXC-13; || c. Product Code LXC-14; || d. Product Code LXC-15; || e. Product Code LXC-16; || f. Product Code LXC-17; || Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
  • Manufacturer
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