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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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Cobra PzF - 00879397000661

NanoCoated Coronary Stent System
CELONOVA BIOSCIENCES, INC.
170-03-25012
In Commercial Distribution

  • 00879397000661 ()

  • Length: 12 Millimeter
  • Lumen/Inner Diameter: 2.50 Millimeter
170-03-25012

  • Bare-metal coronary artery stent

Cobra PzF - 00879397000654

NanoCoated Coronary Stent System
CELONOVA BIOSCIENCES, INC.
170-03-25008
In Commercial Distribution

  • 00879397000654 ()

  • Length: 8 Millimeter
  • Lumen/Inner Diameter: 2.50 Millimeter
170-03-25008

  • Bare-metal coronary artery stent

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

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

26MM X 3CM X 55CM ASCENDRA 3 DELIVERY SYSTEM - 00690103191936

No Description
Edwards Lifesciences LLC
9120AS26A
In Commercial Distribution

  • 00690103191936 ()

  • 26 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9120AS26A

  • Cardiac valvuloplasty catheter

23MM X 3CM X 55CM ASCENDRA 3 DELIVERY SYSTEM - 00690103191929

No Description
Edwards Lifesciences LLC
9120AS23A
In Commercial Distribution

  • 00690103191929 ()

  • 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9120AS23A

  • Cardiac valvuloplasty catheter

Tryton Side Branch Stent - 00894588002187

No Description
TRYTON MEDICAL, INC.
T5-3035-151-US
In Commercial Distribution

  • 00894588002187 ()

  • Distal Inner Diameter = 3.0mm, Proximal Inner Diameter = 3.5mm
  • Stent Length = 15mm
T5-3035-151-US

  • Bare-metal coronary artery stent

Tryton Side Branch Stent - 00894588002170

No Description
TRYTON MEDICAL, INC.
T5-3540-151-US
In Commercial Distribution

  • 00894588002170 ()

  • Distal Inner Diameter = 3.5mm, Proximal Inner Diameter = 4.0mm
  • Stent Length = 15mm
T5-3540-151-US

  • Bare-metal coronary artery stent
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