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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 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-IL1412100-J
In Commercial Distribution

  • 00850007370169 ()

  • Stent Diameter: 12 Millimeter
  • Stent Diameter: 14 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 100 Millimeter
TV-IL1412100-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-IL141280-J
In Commercial Distribution

  • 00850007370152 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 12 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 80 Millimeter
TV-IL141280-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-IL1410140-J
In Commercial Distribution

  • 00850007370145 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 10 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 140 Millimeter
TV-IL1410140-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-IL1410120-J
In Commercial Distribution

  • 00850007370138 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 10 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 120 Millimeter
TV-IL1410120-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-IL1410100-J
In Commercial Distribution

  • 00850007370121 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 10 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 100 Millimeter
TV-IL1410100-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-IL1410160-J
In Commercial Distribution

  • 00850007370114 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 10 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 160 Millimeter
TV-IL1410160-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-IL141480-J
In Commercial Distribution

  • 00850007370107 ()

  • Stent Diameter: 14 Millimeter
  • Catheter Gauge: 60 French
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 80 Millimeter
TV-IL141480-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-IL1428140-J
In Commercial Distribution

  • 00850007370091 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 28 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 15 Femtometer
  • Lumen/Inner Diameter: 13 Femtometer
  • Stent Length: 140 Millimeter
TV-IL1428140-J

  • Abdominal aorta endovascular stent-graft
The Autoinjector 2 is a component of the Alto™ Abdominal Stent Graft System. The Autoinjector 2 applies controlled force to the syringe plunger of the CustomSeal Kit to inject the fill polymer into the graft until pressure equilibrium is reached and complete fill of the primary sealing ring, fill channels, and support rings in the graft material the of the aortic body is achieved.
Endologix, Inc.
TV-AI01-N
In Commercial Distribution

  • M701TVAI01N1 ()
TV-AI01-N

  • Abdominal aorta endovascular stent-graft
The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.
Ascension Orthopedics, Inc.
MS252222
In Commercial Distribution

  • M268MS2522221 ()
  • 10381780121510 ()

  • 25 mm W x 22 mm L x 22 mm L
MS252222

  • Orthopaedic bone staple, non-adjustable
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