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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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No Description
Edwards Lifesciences LLC
916ES
In Commercial Distribution

  • 00690103193992 ()

  • 16F
916ESA

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
No Description
Edwards Lifesciences LLC
914ES
In Commercial Distribution

  • 00690103193985 ()

  • 14F
914ESA

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
No Description
Edwards Lifesciences LLC
9600CR
In Commercial Distribution

  • 00690103193978 ()

  • NOT APPLICABLE
9600CRA

  • Basic crimper
EDWARDS COMMANDER DELIVERY SYSTEM
Edwards Lifesciences LLC
9600LDS29
In Commercial Distribution

  • 00690103193961 ()

  • 29 MM
9600LDS29A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
EDWARDS COMMANDER DELIVERY SYSTEM
Edwards Lifesciences LLC
9600LDS26
In Commercial Distribution

  • 00690103193954 ()

  • 26 MM
9600LDS26A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Mitral transcatheter heart valve bioprosthesis
EDWARDS COMMANDER DELIVERY SYSTEM
Edwards Lifesciences LLC
9600LDS23
In Commercial Distribution

  • 00690103193947 ()

  • 23 MM
9600LDS23A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Mitral transcatheter heart valve bioprosthesis
EDWARDS COMMANDER DELIVERY SYSTEM
Edwards Lifesciences LLC
9600LDS20
In Commercial Distribution

  • 00690103193930 ()

  • 20 MM
9600LDS20A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
EDWARDS INTUITY ELITE DELIVERY SYSTEM
Edwards Lifesciences LLC
8300DB27
In Commercial Distribution

  • 00690103192582 ()

  • VALVE STENT DIAMETER, 27 MM
8300DB27

  • Cardiac valvuloplasty catheter
EDWARDS INTUITY ELITE DELIVERY SYSTEM
Edwards Lifesciences LLC
8300DB25
In Commercial Distribution

  • 00690103192575 ()

  • VALVE STENT DIAMETER, 25 MM
8300DB25

  • Cardiac valvuloplasty catheter
EDWARDS INTUITY ELITE DELIVERY SYSTEM
Edwards Lifesciences LLC
8300DB23
In Commercial Distribution

  • 00690103192568 ()

  • VALVE STENT DIAMETER, 23 MM
8300DB23

  • Cardiac valvuloplasty catheter
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