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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 - 00821684036426

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-07-37-080
In Commercial Distribution

  • 00821684036426 ()

  • Catheter Gauge: 6 French
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT;
  • Outer Diameter: 2.2 Millimeter
  • Length: 37 Millimeter
  • Outer Diameter: 7 Millimeter


  • Bare-metal biliary stent

Visi-Pro - 00821684036402

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-07-27-080
In Commercial Distribution

  • 00821684036402 ()

  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT;
  • Catheter Gauge: 6 French
  • Length: 27 Millimeter
  • Outer Diameter: 2.2 Millimeter
  • Outer Diameter: 7 Millimeter


  • Bare-metal biliary stent

Visi-Pro - 00821684036389

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-07-17-080
In Commercial Distribution

  • 00821684036389 ()

  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT;
  • Catheter Gauge: 6 French
  • Outer Diameter: 7 Millimeter
  • Length: 17 Millimeter
  • Outer Diameter: 2.2 Millimeter


  • Bare-metal biliary stent

Visi-Pro - 00821684036372

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-07-12-080
In Commercial Distribution

  • 00821684036372 ()

  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT;
  • Catheter Gauge: 6 French
  • Outer Diameter: 7 Millimeter
  • Length: 12 Millimeter
  • Outer Diameter: 2.2 Millimeter


  • Bare-metal biliary stent

Visi-Pro - 00821684036358

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-06-57-080
In Commercial Distribution

  • 00821684036358 ()

  • Length: 57 Millimeter
  • Outer Diameter: 6 Millimeter
  • Outer Diameter: 2.2 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 - 00821684036334

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-06-37-080
In Commercial Distribution

  • 00821684036334 ()

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


  • Bare-metal biliary stent

Visi-Pro - 00821684036310

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-06-27-080
In Commercial Distribution

  • 00821684036310 ()

  • Outer Diameter: 2.2 Millimeter
  • Length: 27 Millimeter
  • Outer Diameter: 6 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 - 00821684036297

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-06-17-080
In Commercial Distribution

  • 00821684036297 ()

  • Catheter Gauge: 6 French
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,8,AT;
  • Outer Diameter: 2.2 Millimeter
  • Outer Diameter: 6 Millimeter
  • Length: 17 Millimeter


  • Bare-metal biliary stent

Visi-Pro - 00821684036280

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-06-12-080
In Commercial Distribution

  • 00821684036280 ()

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


  • Bare-metal biliary stent

Visi-Pro - 00821684036266

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-05-57-080
In Commercial Distribution

  • 00821684036266 ()

  • Outer Diameter: 2.2 Millimeter
  • Length: 57 Millimeter
  • Outer Diameter: 5 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 - 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

Visi-Pro - 00821684036204

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-05-17-080
In Commercial Distribution

  • 00821684036204 ()

  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 6 French
  • Outer Diameter: 2.2 Millimeter
  • Length: 17 Millimeter
  • Outer Diameter: 5 Millimeter


  • Bare-metal biliary stent

Visi-Pro - 00821684036198

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-05-12-080
In Commercial Distribution

  • 00821684036198 ()

  • Length: 12 Millimeter
  • Outer Diameter: 2.2 Millimeter
  • Outer Diameter: 5 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

Fortrex - 00821684057902

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV12080080
In Commercial Distribution

  • 00821684057902 ()

  • Length: 80 Centimeter
  • Outer Diameter: 12 Millimeter
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,7,AT;Rated Burst Pressure,12,AT;
  • Catheter Gauge: 7 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057896

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV12080040
In Commercial Distribution

  • 00821684057896 ()

  • Length: 40 Centimeter
  • Outer Diameter: 12 Millimeter
  • Catheter Gauge: 7 French
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,7,AT;Rated Burst Pressure,12,AT;


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057889

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV12040135
In Commercial Distribution

  • 00821684057889 ()

  • Length: 135 Centimeter
  • Outer Diameter: 12 Millimeter
  • Catheter Gauge: 7 French
  • Balloon Length,40,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,8,AT;Rated Burst Pressure,14,AT;


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057872

0.035 IN OTW PTA Balloon Catheter
Covidien LP
A35HPV12040080
In Commercial Distribution

  • 00821684057872 ()

  • Outer Diameter: 12 Millimeter
  • Length: 80 Centimeter
  • Catheter Gauge: 7 French
  • Balloon Length,40,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,8,AT;Rated Burst Pressure,14,AT;


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057865

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV12040040
In Commercial Distribution

  • 00821684057865 ()

  • Outer Diameter: 12 Millimeter
  • Length: 40 Centimeter
  • Catheter Gauge: 7 French
  • Balloon Length,40,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,8,AT;Rated Burst Pressure,14,AT;


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057858

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV10080135
In Commercial Distribution

  • 00821684057858 ()

  • Outer Diameter: 10 Millimeter
  • Length: 135 Centimeter
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,8,AT;Rated Burst Pressure,16,AT;
  • Catheter Gauge: 7 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057841

0.035 IN OTW PTA Balloon Catheter
Covidien LP
A35HPV10080080
In Commercial Distribution

  • 00821684057841 ()

  • Length: 80 Centimeter
  • Outer Diameter: 10 Millimeter
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,8,AT;Rated Burst Pressure,16,AT;
  • Catheter Gauge: 7 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057810

0.035 IN OTW PTA Balloon Catheter
Covidien LP
A35HPV10040080
In Commercial Distribution

  • 00821684057810 ()

  • Outer Diameter: 10 Millimeter
  • Length: 80 Centimeter
  • Catheter Gauge: 7 French
  • Balloon Length,40,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,8,AT;Rated Burst Pressure,16,AT;


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057773

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV09080040
In Commercial Distribution

  • 00821684057773 ()

  • Length: 40 Centimeter
  • Outer Diameter: 9 Millimeter
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;
  • Catheter Gauge: 7 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057759

0.035 IN OTW PTA Balloon Catheter
Covidien LP
A35HPV09040080
In Commercial Distribution

  • 00821684057759 ()

  • Length: 80 Centimeter
  • Outer Diameter: 9 Millimeter
  • Balloon Length,40,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;
  • Catheter Gauge: 7 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057735

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV08100135
In Commercial Distribution

  • 00821684057735 ()

  • Length: 135 Centimeter
  • Outer Diameter: 8 Millimeter
  • Balloon Length,100,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;
  • Catheter Gauge: 6 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057728

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV08100080
In Commercial Distribution

  • 00821684057728 ()

  • Balloon Length,100,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;
  • Catheter Gauge: 6 French
  • Length: 80 Centimeter
  • Outer Diameter: 8 Millimeter


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057711

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV08100040
In Commercial Distribution

  • 00821684057711 ()

  • Length: 40 Centimeter
  • Outer Diameter: 8 Millimeter
  • Balloon Length,100,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;
  • Catheter Gauge: 6 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057704

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV08080135
In Commercial Distribution

  • 00821684057704 ()

  • Outer Diameter: 8 Millimeter
  • Length: 135 Centimeter
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,19,AT;
  • Catheter Gauge: 6 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057698

0.035 IN OTW PTA Balloon Catheter
Covidien LP
A35HPV08080080
In Commercial Distribution

  • 00821684057698 ()

  • Length: 80 Centimeter
  • Outer Diameter: 8 Millimeter
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,19,AT;
  • Catheter Gauge: 6 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057674

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV08040135
In Commercial Distribution

  • 00821684057674 ()

  • Outer Diameter: 8 Millimeter
  • Length: 135 Centimeter
  • Catheter Gauge: 6 French
  • Balloon Length,40,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,20,AT;


  • Peripheral angioplasty balloon catheter, basic
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