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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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ROD 8586 CATHETER TUNNELING(60CM) US
MEDTRONIC, INC.
8586
In Commercial Distribution

  • 00721902620898 ()

  • Length: 38.0 Centimeter


  • Subcutaneous tunneller, single-use
Edwards EVOQUE Valve, 56mm
Edwards Lifesciences LLC
9850EV56US
In Commercial Distribution

  • 00690103219074 ()
9850EV56US

  • Tricuspid transcatheter heart valve bioprosthesis
Edwards EVOQUE Tricuspid Delivery System
Edwards Lifesciences LLC
9850TDSUS
In Commercial Distribution

  • 00690103217520 ()
9850TDSUS

  • Tricuspid transcatheter heart valve bioprosthesis
EDWARDS EVOQUE VALVE, 52MM
Edwards Lifesciences LLC
9850EV52US
In Commercial Distribution

  • 00690103217469 ()

  • Outer Diameter: 52 Millimeter
9850EV52US

  • Tricuspid transcatheter heart valve bioprosthesis
EDWARDS EVOQUE VALVE, 48MM
Edwards Lifesciences LLC
9850EV48US
In Commercial Distribution

  • 00690103217452 ()

  • Outer Diameter: 48 Millimeter
9850EV48US

  • Tricuspid transcatheter heart valve bioprosthesis
EDWARDS EVOQUE VALVE, 44MM
Edwards Lifesciences LLC
9850EV44US
In Commercial Distribution

  • 00690103217445 ()

  • Outer Diameter: 44 Millimeter
9850EV44US

  • Tricuspid transcatheter heart valve bioprosthesis
SAPIEN 3 Ultra valve with Commander Delivery System
Edwards Lifesciences LLC
9750CM20
In Commercial Distribution

  • 00690103207811 ()

  • Outer Diameter: 20.0000 Millimeter
9750CM20A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
EDWARDS CERTITUDE DELIVERY SYSTEM
Edwards Lifesciences LLC
9600SDS29
In Commercial Distribution

  • 00690103194166 ()

  • NOMINAL DEPLOYED BALLOON DIAMETER 29 MILLIMETER
9600SDS29A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
EDWARDS CERTITUDE DELIVERY SYSTEM
Edwards Lifesciences LLC
9600SDS26
In Commercial Distribution

  • 00690103194159 ()

  • NOMINAL DEPLOYED BALLOON DIAMETER 26 MILLIMETER
9600SDS26A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
EDWARDS CERTITUDE DELIVERY SYSTEM
Edwards Lifesciences LLC
9600SDS23
In Commercial Distribution

  • 00690103194142 ()

  • NOMINAL DEPLOYED BALLOON DIAMETER 23 MILLIMETER
9600SDS23A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
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