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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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EverCross - 00821684038987

.035
Covidien LP
AB35W03030080
In Commercial Distribution

  • 00821684038987 ()

  • Outer Diameter: 3 Millimeter
  • Length: 30 Millimeter
  • Catheter Gauge: 5 French
  • Working Length,80,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,20,AT;Nominal Pressure,10,AT;


  • Peripheral angioplasty balloon catheter, basic

EverCross - 00821684038970

.035
Covidien LP
AB35W03020080
In Commercial Distribution

  • 00821684038970 ()

  • Length: 20 Millimeter
  • Outer Diameter: 3 Millimeter
  • Catheter Gauge: 5 French
  • Working Length,80,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,20,AT;Nominal Pressure,10,AT;


  • Peripheral angioplasty balloon catheter, basic

Visi-Pro - 00821684036686

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-10-57-080
In Commercial Distribution

  • 00821684036686 ()

  • Length: 57 Millimeter
  • Outer Diameter: 10 Millimeter
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT;
  • Catheter Gauge: 7 French


  • Bare-metal biliary stent

Visi-Pro - 00821684036662

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-10-37-080
In Commercial Distribution

  • 00821684036662 ()

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


  • Bare-metal biliary stent

Visi-Pro - 00821684036648

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-10-27-080
In Commercial Distribution

  • 00821684036648 ()

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


  • Bare-metal biliary stent

Visi-Pro - 00821684036624

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-10-17-080
In Commercial Distribution

  • 00821684036624 ()

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


  • Bare-metal biliary stent

Visi-Pro - 00821684036600

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-09-57-080
In Commercial Distribution

  • 00821684036600 ()

  • Length: 57 Millimeter
  • Outer Diameter: 9 Millimeter
  • Catheter Gauge: 7 French
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT;


  • Bare-metal biliary stent

Visi-Pro - 00821684036587

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-09-37-080
In Commercial Distribution

  • 00821684036587 ()

  • Length: 37 Millimeter
  • Outer Diameter: 9 Millimeter
  • Catheter Gauge: 7 French
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT;


  • Bare-metal biliary stent

Visi-Pro - 00821684036563

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-09-27-080
In Commercial Distribution

  • 00821684036563 ()

  • Length: 27 Millimeter
  • Outer Diameter: 9 Millimeter
  • Catheter Gauge: 7 French
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT;


  • Bare-metal biliary stent

Visi-Pro - 00821684036549

Balloon-Expandable Biliary Stent System
Covidien LP
PXB35-09-17-080
In Commercial Distribution

  • 00821684036549 ()

  • Outer Diameter: 9 Millimeter
  • Length: 17 Millimeter
  • Catheter Gauge: 7 French
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT;


  • Bare-metal biliary stent

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 - 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

Enteer - 00821684052747

Re-entry Catheter
Covidien LP
ENB-375-20-135
In Commercial Distribution

  • 00821684052747 ()

  • Outer Diameter: 3.75 Millimeter
  • Length: 20 Millimeter
  • Catheter Gauge: 5 French
  • Working Length,135,Centimeter;Compatible Guidewire,.018,Inch;Rated Burst Pressure,4,AT;Nominal Pressure,3,AT;


  • Vascular guide-catheter, single-use

Enteer - 00821684052730

Re-entry Catheter
Covidien LP
ENB-275-20-150
In Commercial Distribution

  • 00821684052730 ()

  • Length: 20 Millimeter
  • Outer Diameter: 2.75 Millimeter
  • Working Length,150,Centimeter;Compatible Guidewire,.018,Inch;Rated Burst Pressure,4,AT;Nominal Pressure,3,AT;
  • Catheter Gauge: 5 French


  • Vascular guide-catheter, single-use

RapidCross - 00821684051108

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040150170
In Commercial Distribution

  • 00821684051108 ()

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


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684051092

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040120170
In Commercial Distribution

  • 00821684051092 ()

  • Length: 120 Millimeter
  • Outer Diameter: 4 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 - 00821684051085

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040100170
In Commercial Distribution

  • 00821684051085 ()

  • Length: 100 Millimeter
  • Outer Diameter: 4 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 - 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 - 00821684051061

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040060170
In Commercial Distribution

  • 00821684051061 ()

  • Outer Diameter: 4 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 - 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
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