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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The TriVascular Ovation Prime Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.
Trivascular, Inc.
Aortic Body
In Commercial Distribution

  • M701TVAB2680E1 ()

  • Catheter Gauge: 14 French
  • Outer Diameter: 26 Millimeter
TV-AB2680-E

  • Abdominal aorta endovascular stent-graft
The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The Alto™ Abdominal Stent Graft System includes: an Aortic Body Stent Graft and delivery catheter, Ovation iX™ Iliac Limb Stent Grafts and delivery catheters, Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required), the CustomSeal™ Polymer Fill Kit, and the Autoinjector 2.
Endologix, Inc.
TV-AB2380-N
In Commercial Distribution

  • M701TVAB2380N1 ()

  • Stent Graft Proximal Diameter
  • Catheter Working Length
  • Delivery System Outer Profile
  • Integral Sheath Inner Diameter
  • Covered Stent Graft Length
TV-AB2380-N

  • Abdominal aorta endovascular stent-graft
The TriVascular® Ovation iX™ Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal stent graft aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs and iliac extensions as required. The TriVascular Ovation iX Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Kit, and an Autoinjector.
Trivascular, Inc.
Aortic Body
In Commercial Distribution

  • M701TVAB2380J1 ()

  • Outer Diameter: 23 Millimeter
  • Catheter Gauge: 14 French
TV-AB2380-J

  • Abdominal aorta endovascular stent-graft
The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The TriVascular Ovation Prime Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.
Trivascular, Inc.
Aortic Body
In Commercial Distribution

  • M701TVAB2380E1 ()

  • Catheter Gauge: 14 French
  • Outer Diameter: 23 Millimeter
TV-AB2380-E

  • Abdominal aorta endovascular stent-graft
The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The Alto™ Abdominal Stent Graft System includes: an Aortic Body Stent Graft and delivery catheter, Ovation iX™ Iliac Limb Stent Grafts and delivery catheters, Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required), the CustomSeal™ Polymer Fill Kit, and the Autoinjector 2.
Endologix, Inc.
TV-AB2080-N
In Commercial Distribution

  • M701TVAB2080N1 ()

  • Stent Graft Proximal Diameter
  • Catheter Working Length
  • Delivery System Outer Profile
  • Integral Sheath Inner Diameter
  • Covered Stent Graft Length
TV-AB2080-N

  • Abdominal aorta endovascular stent-graft
The TriVascular® Ovation iX™ Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal stent graft aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs and iliac extensions as required. The TriVascular Ovation iX Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Kit, and an Autoinjector.
Trivascular, Inc.
Aortic Body
In Commercial Distribution

  • M701TVAB2080J1 ()

  • Outer Diameter: 20 Millimeter
  • Catheter Gauge: 14 French
TV-AB2080-J

  • Abdominal aorta endovascular stent-graft
The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The TriVascular Ovation Prime Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.
Trivascular, Inc.
Aortic Body
In Commercial Distribution

  • M701TVAB2080E1 ()

  • Catheter Gauge: 14 French
  • Outer Diameter: 20 Millimeter
TV-AB2080-E

  • Abdominal aorta endovascular stent-graft
Pudenz Ventricular Catheter
NATUS MEDICAL INCORPORATED
NT96001S01
In Commercial Distribution


  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 20cm (8") (all dimensions nominal)
NT96001S01

  • Intracerebral infusion/drainage catheter, long-term
Side-Inlet Natus® CSF Reservoir
NATUS MEDICAL INCORPORATED
NT8501212
In Commercial Distribution


  • Reservoir: 2.5cm I.D.; Inlet Integral Connector: 1.1mm I.D. x 1.9mm O.D. (All dimensions nominal)
NT8501212

  • Intracerebral infusion/drainage catheter, long-term
Portnoy Ventricular Catheter With Stylet
NATUS MEDICAL INCORPORATED
NT8501229
In Commercial Distribution


  • 1.3mm I.D. x 2.2mm O.D.; Total Length: 18cm (7") (all dimensions nominal)
NT8501229

  • Intracerebral infusion/drainage catheter, long-term
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