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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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Ovation iX Iliac Stent Graft - 00850007370213

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

Ovation iX Iliac Stent Graft - 00850007370107

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

Ovation iX Iliac Stent Graft - 00850007370039

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

Ovation iX Iliac Stent Graft - 00850007370022

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

Ovation iX Iliac Stent Graft - 00850007370428

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

PERFLUORON - 00380659001642

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

PERFLUORON - 00380659001635

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

MEDTRONIC CARELINK® MONITOR - 00643169376823

MON 2490C16 USA C16 HPMRI
MEDTRONIC, INC.
2490C16
Not in Commercial Distribution

  • 00643169376823 ()


  • Cardiac pulse generator reader, home-use

MEDTRONIC CARELINK® MONITOR - 00643169191815

MON 2490C15 USA C15 60601
MEDTRONIC, INC.
2490C15
Not in Commercial Distribution

  • 00643169191815 ()


  • Cardiac pulse generator reader, home-use

Medtronic Guardian™ Link - 00643169283183

CHARGER MMT-7715 MLNK GST3 21L RPL
MEDTRONIC MINIMED, INC.
MMT-7715
In Commercial Distribution

  • 00643169283183 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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