Torax Medical, Inc.

5 devices in the database

  • Model / 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
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    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.
  • Product Description
    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.
  • Model / Serial
    a. Product Code LX-12, Part No. 2684-12, GTIN 00855106005073;  b. Product Code LX-13, Part No. 2684-13, GTIN 00855106005080;  c. Product Code LX-14, Part No. 2684-14, GTIN 00855106005097;  d. Product Code LX-15, Part No. 2684-15, GTIN 00855106005103;  e. Product Code LX-16, Part No. 2684-16, GTIN 00855106005110;  f. Product Code LX-17, Part No. 2684-17, GTIN 00855106005127;   Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    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.
  • Product Description
    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: || a. Product Code LX-12; || b. Product Code LX-13; || c. Product Code LX-14; || d. Product Code LX-15; || e. Product Code LX-16; || f. Product Code LX-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.
  • Model / Serial
    a. Product Code LXMC-13, Part No. 4550-13, GTIN 00855106005332;  b. Product Code LXMC-14, Part No. 4550-14, GTIN 00855106005349;  c. Product Code LXMC-15, Part No. 4550-15, GTIN 00855106005356;  d. Product Code LXMC-16, Part No. 4550-16, GTIN 00855106005363;  e. Product Code LXMC-17, Part No. 4550-17, GTIN 00855106005370;   Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    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.
  • Product Description
    LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: || a. Product Code LXMC-13; || b. Product Code LXMC-14; || c. Product Code LXMC-15; || d. Product Code LXMC-16; || e. Product Code LXMC-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.
  • Model / 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
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    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.
  • Product Description
    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.
  • Model / 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
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    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.
  • Product Description
    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.