أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 32390 - drill bit, surgical - a reusable drill bit intended for use during orthopaedic surgery.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 32854 - orthopaedic bone pin, non-bioabsorbable - a reusable device intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 35325 - scissors, - a non-sterile, reusable surgical scissor intended to cut, e.g. tissue, cloth or sutures.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

arthrex australia pty ltd - 62787 - orthopaedic surgical distractor, external - a reusable, hand-operated surgical instrument designed to non-invasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

arthrex australia pty ltd - 35095 - surgical drill guide, reusable - a hand-held manual reusable device intended to navigate a drill bit and/or protect the surrounding soft tissue during a surgical procedure.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

symbios orthopaedics pty ltd - 12696 - orthopaedic implant inserter/extractor - a reusable surgical instrument designed to insert or extract surgical pins.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 47932 - multiple peripheral arteries stent - a balloon-expandable cocr stent, covered with eptfe graft material, pre-mounted on the balloon of an over the wire (otw) delivery system. available in 3 stent designs. ?12 & 14mm can be maximally post-dilated with an appropriate balloon to 20mm, ?16 & 18mm can be post-dilated to 24mm & ?20 ? 24mm can be post-dilated to 30mm. compatible with 0.035? (0.89mm) guide wires. two radiopaque markers located underneath the balloon fluoroscopically identify the position of the stent on the balloon. the ?begraft aortic stent graft system? is indicated for; ? the implantation in the native and/or recurrent coarctation of the aorta (coa) on adolescent or adult patients with the following clinical conditions: -- stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or noninvasive imaging, i.e. echocardiography, magnetic resonance imaging (mri), ct scan; -- stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function; -- stenosis of the aorta where balloon angioplasty is ineffective or contraindicated; -- stenosis diameter <20% of the adjacent vessel diameter. stenosis that would present increased risk of vascular damage of disruption. ? and furthermore for restoring and improving the patency of the iliac arteries.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 47932 - multiple peripheral arteries stent - the system consists of; a balloon-expandable cobalt-chromium (l605) stent, covered with an eptfe graft material, which is pre-mounted on the balloon of an over the wire (otw) stent delivery system. the delivery system is compatible with 0.035? (0.89mm) guide wires and is available in usable lengths of 75cm and 120cm. two radiopaque markers located underneath the balloon identify the begraft peripheral stent position and fluoroscopically mark the working length of the balloon. the begraft peripheral stent graft system is indicated for intraluminal chronic placement in iliac and renal arteries for: ? restoring and improving the patency and ? treating aneurysms, acute perforations, acute ruptures and fistulas.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 57788 - mesh-sleeve coronary artery stent - the begraft coronary stent graft system consists of: - a balloon-expandable cobalt-chromium (l605) stent, covered with an eptfe graft material, which is - pre-mounted on the balloon of a rapid exchange (rx)stent delivery system. the delivery system is compatible with 0.014? guide wires and is available in usable lengths of 143 cm and 153 cm. the begraft coronary stent graft system is indicated for transluminal implantation in coronary arteries or aorto-coronary bypass grafts for the treatment of: 1. acute perforation or rupture of coronary arteries. 2. aneurysm of coronary arteries or coronary bypass-vein graft.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 47932 - multiple peripheral arteries stent - the begraft peripheral plus stent graft system is indicated for intraluminal chronic placement in iliac and renal arteries for: - restoring and improving the patency and - treating aneurysms, acute perforations, acute ruptures and fistulas.