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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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EDWARDS INTUITY ELITE AORTIC VALVE
Edwards Lifesciences LLC
8300AB
In Commercial Distribution

  • 00690103194517 ()

  • STENT DIAMETER, 27 MM
8300AB27A

  • Aortic open-surgery heart valve bioprosthesis
EDWARDS INTUITY ELITE AORTIC VALVE
Edwards Lifesciences LLC
8300AB
In Commercial Distribution

  • 00690103194500 ()

  • STENT DIAMETER, 25 MM
8300AB25A

  • Aortic open-surgery heart valve bioprosthesis
EDWARDS INTUITY ELITE AORTIC VALVE
Edwards Lifesciences LLC
8300AB
In Commercial Distribution

  • 00690103194494 ()

  • STENT DIAMETER, 23 MM
8300AB23A

  • Aortic open-surgery heart valve bioprosthesis
EDWARDS INTUITY ELITE AORTIC VALVE
Edwards Lifesciences LLC
8300AB
In Commercial Distribution

  • 00690103194487 ()

  • STENT DIAMETER, 21 MM
8300AB21A

  • Aortic open-surgery heart valve bioprosthesis
EDWARDS INTUITY ELITE AORTIC VALVE
Edwards Lifesciences LLC
8300AB
In Commercial Distribution

  • 00690103194470 ()

  • STENT DIAMETER, 19 MM
8300AB19A

  • Aortic open-surgery heart valve bioprosthesis
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (29MM)
Edwards Lifesciences LLC
9600TFX
In Commercial Distribution

  • 00690103194364 ()

  • 29 MM
9600TFX29A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Basic crimper
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (26MM)
Edwards Lifesciences LLC
9600TFX
In Commercial Distribution

  • 00690103194357 ()

  • 26 MM
9600TFX26A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (23MM)
Edwards Lifesciences LLC
9600TFX
In Commercial Distribution

  • 00690103194340 ()

  • 23 MM
9600TFX23A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
EDWARDS CERTITUDE INTRODUCER SHEATH SET
Edwards Lifesciences LLC
9600IS21
In Commercial Distribution

  • 00690103194180 ()

  • LUMEN/INNER DIAMETER 21F
9600IS21A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
EDWARDS CERTITUDE INTRODUCER SHEATH SET
Edwards Lifesciences LLC
9600IS18
In Commercial Distribution

  • 00690103194173 ()

  • LUMEN/INNER DIAMETER 18F
9600IS18A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
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