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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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Ovation Prime Abdominal Stent Graft System - M701TVEX141445E1

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.
Iliac Extension
In Commercial Distribution

  • M701TVEX141445E1 ()

  • Catheter Gauge: 13 French
  • Length: 45 Millimeter
  • Outer Diameter: 14 Millimeter
TV-EX141445-E

  • Abdominal aorta endovascular stent-graft

Ovation iX Iliac Stent Graft - M701TVEX121245J1

The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft 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 with the Ovation iX Iliac Stent Graft 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.
ENDOLOGIX, INC.
Iliac Extension
In Commercial Distribution

  • M701TVEX121245J1 ()

  • Catheter Gauge: 12 French
  • Length: 45 Millimeter
  • Outer Diameter: 12 Millimeter
TV-EX121245-J

  • Abdominal aorta endovascular stent-graft

Ovation Prime Abdominal Stent Graft System - M701TVEX121245E1

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.
Iliac Extension
In Commercial Distribution

  • M701TVEX121245E1 ()

  • Catheter Gauge: 13 French
  • Length: 45 Millimeter
  • Outer Diameter: 12 Millimeter
TV-EX121245-E

  • Abdominal aorta endovascular stent-graft

Ovation iX Iliac Stent Graft - M701TVEX101045J1

The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft 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 with the Ovation iX Iliac Stent Graft 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.
ENDOLOGIX, INC.
Iliac Extension
In Commercial Distribution

  • M701TVEX101045J1 ()

  • Catheter Gauge: 12 French
  • Length: 45 Millimeter
  • Outer Diameter: 10 Millimeter
TV-EX101045-J

  • Abdominal aorta endovascular stent-graft

Ovation Prime Abdominal Stent Graft System - M701TVEX101045E1

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.
Iliac Extension
In Commercial Distribution

  • M701TVEX101045E1 ()

  • Catheter Gauge: 13 French
  • Length: 45 Millimeter
  • Outer Diameter: 10 Millimeter
TV-EX101045-E

  • Abdominal aorta endovascular stent-graft

Aranax Anterior Cervical Plating System - M697X0861245STR1

THREE-LEVEL CERVICAL PLATE, 45 mm (56)
Xtant Medical Holdings, Inc.
X086-1245-STR
In Commercial Distribution

  • M697X0861245STR1 ()

  • Length: 45 Millimeter
  • Length: 56 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Aranax Anterior Cervical Plating System - M697X0861134STR1

TWO-LEVEL CERVICAL PLATE, 34 mm (45)
Xtant Medical Holdings, Inc.
X086-1134-STR
In Commercial Distribution

  • M697X0861134STR1 ()

  • Length: 45 Millimeter
  • Length: 34 Millimeter


  • Spinal fixation plate, non-bioabsorbable

L-Box® - M711XLC4514120

PEEK, Ti 6Al 4V (ELI)
Innovasis, Inc.
XLC451412
In Commercial Distribution

  • M711XLC4514120 ()

  • Width: 22 Millimeter
  • Length: 45 Millimeter
  • Height: 14 Millimeter
  • Angle: 12 degree
XLC451412

  • Vertebral body prosthesis, non-sterile
  • Polymeric spinal interbody fusion cage

L-Box® - M711XLC4514070

PEEK, Ti 6Al 4V (ELI)
Innovasis, Inc.
XLC451407
In Commercial Distribution

  • M711XLC4514070 ()

  • Angle: 7 degree
  • Height: 14 Millimeter
  • Length: 45 Millimeter
  • Width: 22 Millimeter
XLC451407

  • Vertebral body prosthesis, non-sterile
  • Polymeric spinal interbody fusion cage

L-Box® - M711XLC4514000

PEEK, Ti 6Al 4V (ELI)
Innovasis, Inc.
XLC451400
In Commercial Distribution

  • M711XLC4514000 ()

  • Angle: 0 degree
  • Height: 14 Millimeter
  • Length: 45 Millimeter
  • Width: 22 Millimeter
XLC451400

  • Vertebral body prosthesis, non-sterile
  • Polymeric spinal interbody fusion cage
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