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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-IL1414120-J
In Commercial Distribution

  • 00850007370213 ()

  • Stent Diameter: 14 Millimeter
  • Catheter Gauge: 16 French
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 120 Millimeter
TV-IL1414120-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 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
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-IL1414100-J
In Commercial Distribution

  • 00850007370428 ()

  • Stent Diameter: 14 Millimeter
  • Catheter Gauge: 60 French
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Shaft Length: 100 Millimeter
TV-IL1414100-J

  • Abdominal aorta endovascular stent-graft
PFNO KIT 7ML<USA Kit Contents: One 7 mL vial of sterile PERFLUORON Liquid One 10 mL syringe One 20 gauge beveled needle One 0.2 micron filter unit One 23 gauge blunt cannula One PERFLUORON Liquid package insert
Alcon Laboratories, Inc.
0090010016
In Commercial Distribution

  • 00380659001642 ()
  • 10380659001649 ()

  • Total Volume: 7 Milliliter
8065900164

  • Aqueous/vitreous humour replacement medium kit
PFNO KIT 5ML<USA Kit Contents: One 5 mL vial of sterile PERFLUORON Liquid One 10 mL syringe One 20 gauge beveled needle One 0.2 micron filter unit One 23 gauge blunt cannula One PERFLUORON Liquid package insert
Alcon Laboratories, Inc.
0090010015
In Commercial Distribution

  • 10380659001632 ()
  • 00380659001635 ()

  • Total Volume: 5 Milliliter
8065900163

  • Aqueous/vitreous humour replacement medium kit
No Description
Stockert GmbH
20403
In Commercial Distribution

  • 04260166374094 ()
M004GEN100204030

  • Cardiac radio-frequency ablation system generator
No Description
Stockert GmbH
20402
In Commercial Distribution

  • 04260166374087 ()
M004GEN100204020

  • Bedside infusion pump, single-channel
No Description
Stockert GmbH
20401
In Commercial Distribution

  • 04260166374070 ()
M004GEN100204010

  • Cardiac radio-frequency ablation system generator
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