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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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No Description
Edwards Lifesciences LLC
9600CR
In Commercial Distribution

  • 00690103198331 ()

  • NOT APPLICABLE
9600CRA

  • Basic crimper
  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
EDWARDS INTUITY ELITE DELIVERY SYSTEM
Edwards Lifesciences LLC
8300DB27
In Commercial Distribution

  • 00690103192582 ()

  • VALVE STENT DIAMETER, 27 MM
8300DB27

  • Cardiac valvuloplasty catheter
EDWARDS INTUITY ELITE DELIVERY SYSTEM
Edwards Lifesciences LLC
8300DB25
In Commercial Distribution

  • 00690103192575 ()

  • VALVE STENT DIAMETER, 25 MM
8300DB25

  • Cardiac valvuloplasty catheter
EDWARDS INTUITY ELITE DELIVERY SYSTEM
Edwards Lifesciences LLC
8300DB23
In Commercial Distribution

  • 00690103192568 ()

  • VALVE STENT DIAMETER, 23 MM
8300DB23

  • Cardiac valvuloplasty catheter
EDWARDS INTUITY ELITE DELIVERY SYSTEM
Edwards Lifesciences LLC
8300DB21
In Commercial Distribution

  • 00690103192551 ()

  • VALVE STENT DIAMETER, 21 MM
8300DB21

  • Cardiac valvuloplasty catheter
EDWARDS INTUITY ELITE DELIVERY SYSTEM
Edwards Lifesciences LLC
8300DB19
In Commercial Distribution

  • 00690103192544 ()

  • VALVE STENT DIAMETER, 19 MM
8300DB19

  • Cardiac valvuloplasty catheter
EDWARDS DILATOR KIT
Edwards Lifesciences LLC
9100DKSA
In Commercial Distribution

  • 00690103192391 ()

  • 22 FRENCH
9100DKSA

  • Vascular catheter introduction set, nonimplantable
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
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 Limb
In Commercial Distribution

  • M701TVIL142880J1 ()

  • Catheter Gauge: 15 French
  • Length: 80 Millimeter
  • Outer Diameter: 28 Millimeter
  • Outer Diameter: 14 Millimeter
TV-IL142880-J

  • Abdominal aorta endovascular stent-graft
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 Limb
In Commercial Distribution

  • M701TVIL1428160J1 ()

  • Catheter Gauge: 15 French
  • Length: 160 Millimeter
  • Outer Diameter: 28 Millimeter
  • Outer Diameter: 14 Millimeter
TV-IL1428160-J

  • Abdominal aorta endovascular stent-graft
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 Limb
In Commercial Distribution

  • M701TVIL1428140J1 ()

  • Catheter Gauge: 15 French
  • Length: 140 Millimeter
  • Outer Diameter: 28 Millimeter
  • Outer Diameter: 14 Millimeter
TV-IL1428140-J

  • Abdominal aorta endovascular stent-graft
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