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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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STENT GRAFT ETUF2814C102E ENDUR II AUI
MEDTRONIC, INC.
ETUF2814C102E
In Commercial Distribution

  • 00643169232594 ()

  • Stent Graft Covered Length 102 MM
  • Stent Graft Proximal Diameter 28 MM
  • Stent Graft Distal Diameter 14 MM


  • Abdominal aorta endovascular stent-graft
STENT GRAFT ETUF2514C102E ENDUR II AUI
MEDTRONIC, INC.
ETUF2514C102E
In Commercial Distribution

  • 00643169232570 ()

  • Stent Graft Proximal Diameter 25 MM
  • Stent Graft Covered Length 102 MM
  • Stent Graft Distal Diameter 14 MM


  • Abdominal aorta endovascular stent-graft
STENT GRAFT ETUF2314C102E ENDUR II AUI
MEDTRONIC, INC.
ETUF2314C102E
In Commercial Distribution

  • 00643169232556 ()

  • Stent Graft Covered Length 102 MM
  • Stent Graft Distal Diameter 14 MM
  • Stent Graft Proximal Diameter 23 MM


  • Abdominal aorta endovascular stent-graft
PGRMR 97740FA SCS W/MRI FIXED ASSET
MEDTRONIC, INC.
97740FA
In Commercial Distribution

  • 00643169208070 ()


  • Multiple active implantable device programmer
ReShape Lap-Band® 2.0, FLEX Tubing Kit
Reshape Lifesciences Inc.
D-3500
In Commercial Distribution

  • 00850007764586 ()
D-3500

  • Gastric band repair kit
The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL141080-J
In Commercial Distribution

  • 00850007370992 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 10 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 80 Millimeter
TV-IL141080-J

  • 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-AB2680-N
In Commercial Distribution

  • 00850007370893 ()

  • Stent Diameter: 26 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 15 Femtometer
  • Lumen/Inner Diameter: 13 Femtometer
  • Stent Length: 80 Millimeter
TV-AB2680-N

  • 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 Kit, and an Autoinjector.
Endologix, Inc.
TV-CS14-G
In Commercial Distribution

  • 00850007370459 ()

  • Total Volume: 14 Milliliter
TV-CS14-G

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL1414160-J
In Commercial Distribution

  • 00850007370435 ()

  • Stent Diameter: 14 Millimeter
  • Catheter Gauge: 60 French
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 160 Millimeter
TV-IL1414160-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL1412160-J
In Commercial Distribution

  • 00850007370411 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 12 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 160 Millimeter
TV-IL1412160-J

  • Abdominal aorta endovascular stent-graft
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