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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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Visi-Pro - 00821684036525

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-08-57-080
In Commercial Distribution

  • 00821684036525 ()

  • Length: 57 Millimeter
  • Outer Diameter: 8 Millimeter
  • Catheter Gauge: 6 French
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT;


  • Bare-metal biliary stent

Visi-Pro - 00821684036501

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-08-37-080
In Commercial Distribution

  • 00821684036501 ()

  • Length: 37 Millimeter
  • Outer Diameter: 2.2 Millimeter
  • Outer Diameter: 8 Millimeter
  • Catheter Gauge: 6 French
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT;


  • Bare-metal biliary stent

Visi-Pro - 00821684036242

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-05-37-080
In Commercial Distribution

  • 00821684036242 ()

  • Outer Diameter: 2.2 Millimeter
  • Outer Diameter: 5 Millimeter
  • Length: 37 Millimeter
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 6 French


  • Bare-metal biliary stent

Visi-Pro - 00821684036228

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-05-27-080
In Commercial Distribution

  • 00821684036228 ()

  • Outer Diameter: 5 Millimeter
  • Length: 27 Millimeter
  • Outer Diameter: 2.2 Millimeter
  • Catheter Gauge: 6 French
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,8,AT;


  • Bare-metal biliary stent

RapidCross - 00821684051078

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040080170
In Commercial Distribution

  • 00821684051078 ()

  • Outer Diameter: 4 Millimeter
  • Length: 80 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684051054

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040040170
In Commercial Distribution

  • 00821684051054 ()

  • Outer Diameter: 4 Millimeter
  • Length: 40 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684051047

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040020170
In Commercial Distribution

  • 00821684051047 ()

  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French
  • Outer Diameter: 4 Millimeter
  • Length: 20 Millimeter


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684051023

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX035150170
In Commercial Distribution

  • 00821684051023 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 150 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684051016

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX035120170
In Commercial Distribution

  • 00821684051016 ()

  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French
  • Length: 120 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684051009

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX035100170
In Commercial Distribution

  • 00821684051009 ()

  • Catheter Gauge: 4 French
  • Length: 100 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050996

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX035080170
In Commercial Distribution

  • 00821684050996 ()

  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French
  • Length: 80 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050989

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX035060170
In Commercial Distribution

  • 00821684050989 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 60 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050972

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX035040170
In Commercial Distribution

  • 00821684050972 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 40 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050965

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX035020170
In Commercial Distribution

  • 00821684050965 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 20 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050941

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030150170
In Commercial Distribution

  • 00821684050941 ()

  • Length: 150 Millimeter
  • Outer Diameter: 3 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050934

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030120170
In Commercial Distribution

  • 00821684050934 ()

  • Length: 120 Millimeter
  • Outer Diameter: 3 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050927

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030100170
In Commercial Distribution

  • 00821684050927 ()

  • Length: 100 Millimeter
  • Outer Diameter: 3 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050910

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030080170
In Commercial Distribution

  • 00821684050910 ()

  • Outer Diameter: 3 Millimeter
  • Length: 80 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050903

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030060170
In Commercial Distribution

  • 00821684050903 ()

  • Length: 60 Millimeter
  • Outer Diameter: 3 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050897

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030040170
In Commercial Distribution

  • 00821684050897 ()

  • Outer Diameter: 3 Millimeter
  • Length: 40 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050880

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030020170
In Commercial Distribution

  • 00821684050880 ()

  • Length: 20 Millimeter
  • Outer Diameter: 3 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050866

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025150170
In Commercial Distribution

  • 00821684050866 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 150 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050859

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025120170
In Commercial Distribution

  • 00821684050859 ()

  • Length: 120 Millimeter
  • Outer Diameter: 2.5 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050842

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025100170
In Commercial Distribution

  • 00821684050842 ()

  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Length: 100 Millimeter
  • Outer Diameter: 2.5 Millimeter


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050835

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025080170
In Commercial Distribution

  • 00821684050835 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 80 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050828

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025060170
In Commercial Distribution

  • 00821684050828 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 60 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050811

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025040170
In Commercial Distribution

  • 00821684050811 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 40 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050804

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025020170
In Commercial Distribution

  • 00821684050804 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 20 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050781

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020150170
In Commercial Distribution

  • 00821684050781 ()

  • Outer Diameter: 2 Millimeter
  • Length: 150 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050774

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020120170
In Commercial Distribution

  • 00821684050774 ()

  • Length: 120 Millimeter
  • Outer Diameter: 2 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050767

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020100170
In Commercial Distribution

  • 00821684050767 ()

  • Length: 100 Millimeter
  • Outer Diameter: 2 Millimeter
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050750

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020080170
In Commercial Distribution

  • 00821684050750 ()

  • Length: 80 Millimeter
  • Outer Diameter: 2 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050743

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020060170
In Commercial Distribution

  • 00821684050743 ()

  • Outer Diameter: 2 Millimeter
  • Length: 60 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050521

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030100090
In Commercial Distribution

  • 00821684050521 ()

  • Length: 100 Millimeter
  • Outer Diameter: 3 Millimeter
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050514

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030080090
In Commercial Distribution

  • 00821684050514 ()

  • Outer Diameter: 3 Millimeter
  • Length: 80 Millimeter
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050507

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030060090
In Commercial Distribution

  • 00821684050507 ()

  • Length: 60 Millimeter
  • Outer Diameter: 3 Millimeter
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050491

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030040090
In Commercial Distribution

  • 00821684050491 ()

  • Outer Diameter: 3 Millimeter
  • Length: 40 Millimeter
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050484

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX030020090
In Commercial Distribution

  • 00821684050484 ()

  • Length: 20 Millimeter
  • Outer Diameter: 3 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050460

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025150090
In Commercial Distribution

  • 00821684050460 ()

  • Length: 150 Millimeter
  • Outer Diameter: 2.5 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050453

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025120090
In Commercial Distribution

  • 00821684050453 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 120 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic
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