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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 Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX282845-J
In Commercial Distribution

  • 00850007370077 ()

  • Stent Diameter: 28 Millimeter
  • Catheter Working Length: 60 Millimeter
  • Outer Diameter: 15 Femtometer
  • Lumen/Inner Diameter: 13 Femtometer
  • Stent Length: 45 Millimeter
TV-EX282845-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX222245-J
In Commercial Distribution

  • 00850007370060 ()

  • Stent Diameter: 22 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 14 Femtometer
  • Lumen/Inner Diameter: 12 Femtometer
  • Stent Length: 45 Millimeter
TV-EX222245-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX181845-J
In Commercial Distribution

  • 00850007370053 ()

  • Stent Diameter: 18 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 13 Femtometer
  • Lumen/Inner Diameter: 11 Femtometer
  • Stent Length: 45 Millimeter
TV-EX181845-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX161645-J
In Commercial Distribution

  • 00850007370046 ()

  • Stent Length: 16 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 13 Femtometer
  • Lumen/Inner Diameter: 11 Femtometer
  • Stent Length: 45 Millimeter
TV-EX161645-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX141445-J
In Commercial Distribution

  • 00850007370039 ()

  • Stent Diameter: 14 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 45 Millimeter
TV-EX141445-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX121245-J
In Commercial Distribution

  • 00850007370022 ()

  • Stent Diameter: 12 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 45 Millimeter
TV-EX121245-J

  • Abdominal aorta endovascular stent-graft
CATHETER 2AF282 ARCTIC FRONT 28MM BLUE
MEDTRONIC, INC.
2AF282
Not in Commercial Distribution

  • 00643169073265 ()

  • Balloon inflation size 28 mm
  • Balloon tip size 9 Fr
  • Catheter shaft size 10.5 Fr
  • Length: 100.0 Centimeter


  • Cardiac cryosurgical system catheter
CATHETER 2AF232 ARCTIC FRONT 23MM RED
MEDTRONIC, INC.
2AF232
Not in Commercial Distribution

  • 00643169073258 ()

  • Length: 100.0 Centimeter
  • Catheter shaft size 10.5 Fr
  • Balloon tip size 9 Fr
  • Balloon inflation size 23 mm


  • Cardiac cryosurgical system catheter
KIT 8543 ISOMED CAP IP20.1 PUMP US MKT
MEDTRONIC, INC.
8543
In Commercial Distribution

  • 00643169072664 ()


  • Neurosurgical procedure kit, non-medicated, single-use
THV 1000-29 3F AORTIC BIO 29MM 1 EA US
MEDTRONIC 3F THERAPEUTICS, INC.
1000-29
Not in Commercial Distribution

  • 00643169072558 ()

  • Valve Inner Diameter 29 MM
  • Valve Height 32 MM


  • Aortic open-surgery heart valve bioprosthesis
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