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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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XVIVO Organ Chamber™ - 07350069520074

The XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a recipient.
Xvivo Perfusion AB
19020
In Commercial Distribution

  • 07350069520074 ()
19020

  • Lung donor-organ preservation/evaluation system lung-interface set

STEEN Solution™ - 07350069520036

STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.
Xvivo Perfusion AB
19004
In Commercial Distribution

  • 07350069520036 ()

  • Total Volume: 500 Milliliter
19004

  • Donor-organ/tissue/cell preservation solution

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis - 00733132659678

EXC TAMBE 31mmx20mmx160mm 22Fr
W. L. Gore & Associates, Inc.
ATAA43120160A
In Commercial Distribution

  • 00733132659678 ()

  • Catheter Gauge: 22 French
  • Length: 16 Centimeter
  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 31 Millimeter
ATAA43120160A

  • Descending thoracic aorta endovascular stent-graft

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis - 00733132659685

EXC TAMBE 37mmX20mmX160mm 22Fr
W. L. Gore & Associates, Inc.
ATAA43720160A
In Commercial Distribution

  • 00733132659685 ()

  • Catheter Gauge: 22 French
  • Length: 16 Centimeter
  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 37 Millimeter
ATAA43720160A

  • Descending thoracic aorta endovascular stent-graft

Ampere™ - 05415067013392

Fiber Cord Assembly Remote
ST. JUDE MEDICAL, INC.
H701339
In Commercial Distribution

  • 05415067013392 ()
H701339

  • Electrical-only medical device connection cable, reusable

Ampere™ - 05415067013385

Fiber Cord Assembly Remote
ST. JUDE MEDICAL, INC.
H701338
In Commercial Distribution

  • 05415067013385 ()
H701338

  • Electrical-only medical device connection cable, reusable

Ampere™ - 05415067013378

Fiber Cord Assembly Remote
ST. JUDE MEDICAL, INC.
H701337
In Commercial Distribution

  • 05415067013378 ()
H701337

  • Electrical-only medical device connection cable, reusable

Ampere™ - 05415067004949

Generator Kit
ST. JUDE MEDICAL, INC.
H700494
In Commercial Distribution

  • 05415067004949 ()
H700494

  • Cardiac radio-frequency ablation system generator

Ampere™ - 05415067004925

Generator and Remote Control
ST. JUDE MEDICAL, INC.
H700492
In Commercial Distribution

  • 05415067004925 ()
H700492

  • Cardiac radio-frequency ablation system generator

Ampere™ - 05415067004901

Remote Control
ST. JUDE MEDICAL, INC.
Remote Control
In Commercial Distribution

  • 05415067004901 ()
H700490

  • Cardiac radio-frequency ablation system generator
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