Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p422
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 422/696)
Character Range: 14781288–14794483

the shaft (denoting the effective balloon length) to aid in the placement of the endoprosthesis. The delivery system is compatible with 0.035" (0.89 mm) guidewires. The delivery system can be used for initial stent placement and post stent dilatation. The premounted stent system is available in a variety of endoprosthesis lengths from 15 to 79 mm and in a variety of diameters from 5 to 11 mm (See Table 1). The premounted endoprosthesis system balloon catheter is also offered in two shaft lengths. This product is supplied sterile. It should not be resterilized.  5mm-11mm diameter                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  $3,867.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 79mm length
GT296                                                                                      GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis                                                                       The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis consists of a 316L surgical grade stainless steel balloon expandable stent and a fluoropolymer graft. The CBAS® Heparin Surface on the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis consists of stable, covalent, end-point attached heparin of porcine origin. The endoprosthesis is premounted on a delivery system equipped with a balloon. The delivery system has two radiopaque balloon markers embedded in the shaft (denoting the effective balloon length) to aid in the placement of the endoprosthesis. The delivery system is compatible with 0.035" (0.89 mm) guidewires. The delivery system can be used for initial stent placement and post stent dilatation. The premounted stent system is available in a variety of endoprosthesis lengths from 15 to 79 mm and in a variety of diameters from 5 to 11 mm (See Table 1). The premounted endoprosthesis system balloon catheter is also offered in two shaft lengths. This product is supplied sterile. It should not be resterilized.  5mm-11mm diameter                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  $3,867.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 15mm, 19mm, 29mm, 39mm & 59mm lengths

  10.02.10.02 - >12mm diameter
     GETINGE AUSTRALIA PTY. LTD.
GX010                                                                                      Advanta V12 Stent Graft System                                                                                             Balloon Expandable PTFE Encapsulated Stainless Steel Vascular Stent                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Large Diameter 12 -16mm. 80 and 120cm catheter lengths                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             $5,140.00

     Pyramed Pty Limited
PY045                                                                                      BeGraft Aortic Stent Graft System                                                                                          Aortic Stent Graft System                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Expanded Diameter: 12mm to 30mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    $5,140.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Stent Length:  19mm to 59mm
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Catheter Length: 75cm and 120cm

  H (heparin)
     W L GORE & ASSOCIATES (AUSTRALIA) PTY LTD
GT294                                                                                      GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis                                                                       The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis consists of a 316L surgical grade stainless steel balloon expandable stent and a fluoropolymer graft. The CBAS® Heparin Surface on the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis consists of stable, covalent, end-point attached heparin of porcine origin. The endoprosthesis is premounted on a delivery system equipped with a balloon. The delivery system has two radiopaque balloon markers embedded in the shaft (denoting the effective balloon length) to aid in the placement of the endoprosthesis. The delivery system is compatible with 0.035" (0.89 mm) guidewires. The delivery system can be used for