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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 Certitude Delivery System
Edwards Lifesciences LLC
9630TA20
In Commercial Distribution

  • 00690103201444 ()

  • Outer Diameter, 20 MM
9630TA20A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
U.S. Edwards SAPIEN 3 Ultra Delivery System (29mm)
Edwards Lifesciences LLC
9630TF29
In Commercial Distribution

  • 00690103201260 ()

  • Outer Diameter, 29 MM
9630TF29A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
26mm SAPIEN 3 Ultra Delivery System
Edwards Lifesciences LLC
9630TF26
In Commercial Distribution

  • 00690103201253 ()

  • Outer Diameter, 26 MM
9630TF26A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
U.S. Edwards SAPIEN 3 Ultra Delivery System (26mm)
Edwards Lifesciences LLC
9630TF23
In Commercial Distribution

  • 00690103201246 ()

  • Outer Diameter, 23 MM
9630TF23A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Edwards SAPIEN 3 Ultra Delivery System (20mm) US
Edwards Lifesciences LLC
9630TF20
In Commercial Distribution

  • 00690103201239 ()

  • Outer Diameter, 20 MM
9630TF20A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Edwards Certitude Delivery System
Edwards Lifesciences LLC
9630TA26
In Commercial Distribution

  • 00690103201192 ()

  • Outer Diameter, 26 MM
9630TA26A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Edwards Certitude Delivery System
Edwards Lifesciences LLC
9630TA23
In Commercial Distribution

  • 00690103201185 ()

  • Outer Diameter, 23 MM
9630TA23A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Axela Sheath (US)
Edwards Lifesciences LLC
9630ES14A
In Commercial Distribution

  • 00690103200782 ()

  • 14F
9630ES14A

  • 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
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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