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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 COMMANDER DELIVERY SYSTEM - 00690103193930

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

KONECT RESILIA - 00690103193855

aortic valved conduit
Edwards Lifesciences LLC
11060A
In Commercial Distribution

  • 00690103193855 ()

  • 25MM
11060A25

  • Aortic open-surgery heart valve bioprosthesis/synthetic polymer aorta graft

26F (8.6MM) X 25CM ASCENDRA+ INTRODUCER SHEATH SET - 00690103193763

ASCENDRA+ INTRODUCER SHEATH SET
Edwards Lifesciences LLC
9350IS29
In Commercial Distribution

  • 00690103193763 ()

  • 29 MILIMETER INNER DIAMETER EXPANSION
9350IS29A

  • Vascular catheter introduction set, nonimplantable

24F (7.9MM) X 25CM ASCENDRA+ INTRODUCER SHEATH SET - 00690103193756

ASCENDRA+ INTRODUCER SHEATH SET
Edwards Lifesciences LLC
9350IS26
In Commercial Distribution

  • 00690103193756 ()

  • 23 MILIMETER INNER DIAMETER EXPANSION
9350IS26A

  • Vascular catheter introduction set, nonimplantable

24F (7.9MM) X 25CM ASCENDRA+ INTRODUCER SHEATH SET - 00690103193749

ASCENDRA+ INTRODUCER SHEATH SET
Edwards Lifesciences LLC
9350IS23
In Commercial Distribution

  • 00690103193749 ()

  • 23 MILIMETER INNER DIAMETER EXPANSION
9350IS23A

  • Vascular catheter introduction set, nonimplantable

29MM X 33MM X 55CM ASCENDRA+ DELIVERY SYSTEM - 00690103193732

29MM ASCENDRA+ DELIVERY SYSTEM
Edwards Lifesciences LLC
9355AS29
In Commercial Distribution

  • 00690103193732 ()

  • 29 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355AS29A

  • Cardiac valvuloplasty catheter

26MM X 29MM X 55CM ASCENDRA+ DELIVERY SYSTEM - 00690103193725

26MM ASCENDRA+ DELIVERY SYSTEM
Edwards Lifesciences LLC
9355AS26
In Commercial Distribution

  • 00690103193725 ()

  • 26 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355AS26A

  • Cardiac valvuloplasty catheter

23MM X 29MM X 55CM ASCENDRA+ DELIVERY SYSTEM - 00690103193718

23MM ASCENDRA+ DELIVERY SYSTEM
Edwards Lifesciences LLC
9355AS23
In Commercial Distribution

  • 00690103193718 ()

  • 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355AS23A

  • Cardiac valvuloplasty catheter

20F X 36CM EDWARDS EXPANDABLE INTRODUCER SHEATH SET - 00690103193466

EDWARDS EXPANDABLE INTRODUCER SHEATH SET
Edwards Lifesciences LLC
920ES29
In Commercial Distribution

  • 00690103193466 ()

  • 20 FRENCH NOMINAL INTRODUCER SHEATH INNER DIAMETER IS COMPATIBLE WITH THE 29 MM VALVE AND DELIVERY SYSTEM
920ES29A

  • Vascular catheter introduction set, nonimplantable

29MM X 3.4CM X 105CM NOVAFLEX+ DELIVERY SYSTEM - 00690103193442

No Description
Edwards Lifesciences LLC
9355FS29
In Commercial Distribution

  • 00690103193442 ()

  • 29 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355FS29A

  • Cardiac valvuloplasty catheter
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