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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 - 00690103194470

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 (THV) - 00690103194364

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 (THV) - 00690103194357

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 (THV) - 00690103194340

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

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS - 00690103194128

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS
Edwards Lifesciences LLC
2800TFX
In Commercial Distribution

  • 00690103194128 ()

  • MOUNTING DIAMETER (ANNULUS), 29 MILLIMETER
2800TFX29MM

  • Aortic open-surgery heart valve bioprosthesis

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS - 00690103194104

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS
Edwards Lifesciences LLC
2800TFX
In Commercial Distribution

  • 00690103194104 ()

  • MOUNTING DIAMETER (ANNULUS), 25 MILLIMETER
2800TFX25MM

  • Aortic open-surgery heart valve bioprosthesis

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS - 00690103194098

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS
Edwards Lifesciences LLC
2800TFX
In Commercial Distribution

  • 00690103194098 ()

  • MOUNTING DIAMETER (ANNULUS), 23 MILLIMETER
2800TFX23MM

  • Aortic open-surgery heart valve bioprosthesis

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTIC - 00690103194081

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC
2800TFX
In Commercial Distribution

  • 00690103194081 ()

  • MOUNTING DIAMETER (ANNULUS), 21 MILLIMETER
2800TFX21MM

  • Aortic open-surgery heart valve bioprosthesis

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTIC - 00690103194074

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC
2800TFX
In Commercial Distribution

  • 00690103194074 ()

  • MOUNTING DIAMETER (ANNULUS), 19 MILLIMETER
2800TFX19MM

  • Aortic open-surgery heart valve bioprosthesis

CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis - 00690103194067

CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis
Edwards Lifesciences LLC
2700TFX
In Commercial Distribution

  • 00690103194067 ()

  • MOUNTING DIAMETER (ANNULUS) 25 MILLIMETER
2700TFX29MM

  • Aortic open-surgery heart valve bioprosthesis
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