Australia - English - Department of Health (Therapeutic Goods Administration)

abbott australasia pty ltd diagnostic division - ct860 - clinical chemistry therapeutic drug monitoring ivds - for the determination of therapeutic drug levels in human clinical specimens.

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 17846 - catheter, intravascular, guiding - the axs infinity ls long sheath is a single lumen, flexible, variable stiffness long sheath. it has a radiopaque marker band on the distal end and a luer hub at proximal end. the axs infinity ls long sheath shaft has a lubricious coating to reduce friction during use. the inner lumen of the axs infinity ls long sheath is compatible with 6f or smaller intermediate catheters. indicated for the introduction of interventional devices into the neuro vasculature.

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 17846 - catheter, intravascular, guiding - the dac is a single lumen braided shaft variable stiffness catheter with a radiopaque marker on the distal end and a luer hub on the proximal end. the catheter shaft has a hydrophilic coating to reduce friction during use. the distal access catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate distal access catheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. it may be used as a diagnostic angiographic catheter. it is also indicated for the removal/aspiration of fresh, soft emboli and thrombi from vessels in the arterial system, including the neurovasculature.

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 32584 - catheter, intravascular, occluding - a braid reinforced coaxial lumen catheter of variable stiffness with a compliant balloon on the distal end. merci balloon guide catheters are intended for use in facilitating the insertion and guidance of an intravascular catheter into a blood vessel in the neurovascular system, providing temporary vascular occlusion and serving as a conduit for retrieval devices.

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 17846 - catheter, intravascular, guiding - the axs offset delivery assist catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and delivery of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. the catheter shaft has a hydrophilic coating to reduce friction during use. the catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing. the axs offset delivery assist catheter is intended to assist in the delivery of interventional devices in the neurovasculature

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 10688 - catheter, angiography - the microcatheters are single-lumen, braided shaft, variable stiffness catheters with a radiopaque marker on the distal end and a luer hub on the proximal end. the catheter shaft has a hydrophilic coating to reduce friction during use. the radiopaque shaft and distal marker facilitate fluoroscopic visualization. a rotating hemostasis valve with side-arm adapter is provided with each microcatheter. indicated for use in the selective placement of devices and/or fluids into the neuro vasculature during diagnostic and/or therapeutic procedures. the microcatheter is intended to be used in combination with other devices: guide catheters, guidewires and retrieval devices.

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the trevo retriever is delivered to the thrombus using a microcatheter. the microcatheter is then retracted to deploy the shaped section of the retriever within the clot. the retriever and microcatheter are pulled back, engaging the thrombus in the shaped section of the retriever. time is allotted for the clot to integrate into the retriever. the retriever, thrombus and the microcatheter are then removed from the body. the kit consists of the retriever, a torque device and an insertion tool. 1. the trevo retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (iv t-pa). endovascular therapy with the device should start within 6 hours of symptom onset. 2. the trevo retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment. 3. the trevo retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ica) or middle cerebral artery (mca)-m1 segments with smaller core infarcts (0-50cc for age <80 years, 0-20cc for age n?80 years). endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the trevo retriever is delivered to the thrombus using a microcatheter. the microcatheter is then retracted to deploy the shaped section of the retriever within the clot. the retriever and microcatheter are pulled back, engaging the thrombus in the shaped section of the retriever. time is allotted for the clot to integrate into the retriever. the retriever, thrombus and the microcatheter are then removed from the body. the kit consists of the retriever, a torque device and an insertion tool. 1. the trevo retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (iv t-pa). endovascular therapy with the device should start within 6 hours of symptom onset. 2. the trevo retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment. 3. the trevo retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ica) or middle cerebral artery (mca)-m1 segments with smaller core infarcts (0-50cc for age <80 years, 0-20cc for age n?80 years). endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 32584 - catheter, intravascular, occluding - a coaxial-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. a compliant balloon is flush mounted on the distal end. flowgate 2 balloon guide catheters are intended for use in facilitating the insertion and guidance of an intravascular catheter into a blood vessel in the neurovascular system, providing temporary vascular occlusion, and serving as a conduit for retrieval devices.

Australia - English - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 32854 - orthopaedic bone pin, non-bioabsorbable - used in orthopaedic surgical procedures, a small rod-shaped fixation device that is temporarily fixed into the bone. this device must be sterilized before use.