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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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Stellarex - 00813132025014

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 100mm) x 135cm
Spectranetics Corporation
AB35SX050100135
In Commercial Distribution

  • 00813132025014 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050100135

  • Peripheral angioplasty balloon catheter, drug-coated

EverFlex - 00821684051726

Self-expanding Peripheral Stent with Entrust Delivery System
Covidien LP
EVD35-07200150
In Commercial Distribution

  • 00821684051726 ()

  • Catheter Gauge: 5 French
  • Working Length,150,Centimeter;Compatible Guidewire,.035,Inch; lumen diameter 5.5-6.5; MM;
  • Length: 200 Millimeter
  • Outer Diameter: 7 Millimeter
EVD35-07200150

  • Peripheral artery stent, bare-metal

EverFlex - 00821684051641

Self-expanding Peripheral Stent with Entrust Delivery System
Covidien LP
EVD35-06200150
In Commercial Distribution

  • 00821684051641 ()

  • Length: 200 Millimeter
  • Catheter Gauge: 5 French
  • Working Length,150,Centimeter;Compatible Guidewire,.035,Inch; lumen diameter 4.5-5.5; MM;
  • Outer Diameter: 6 Millimeter
EVD35-06200150

  • Peripheral artery stent, bare-metal

EverFlex - 00821684051481

Self-expanding Peripheral Stent with Entrust Delivery System
Covidien LP
EVD35-07200120
In Commercial Distribution

  • 00821684051481 ()

  • Length: 200 Millimeter
  • Working Length,120,Centimeter;Compatible Guidewire,.035,Inch; lumen diameter 5.5-6.5; MM;
  • Outer Diameter: 7 Millimeter
  • Catheter Gauge: 5 French
EVD35-07200120

  • Peripheral artery stent, bare-metal

EverFlex - 00821684051405

Self-expanding Peripheral Stent with Entrust Delivery System
Covidien LP
EVD35-06200120
In Commercial Distribution

  • 00821684051405 ()

  • Working Length,120,Centimeter;Compatible Guidewire,.035,Inch; lumen diameter 4.5-5.5; MM;
  • Length: 200 Millimeter
  • Catheter Gauge: 5 French
  • Outer Diameter: 6 Millimeter
EVD35-06200120

  • Peripheral artery stent, bare-metal

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550281

5mm x 200mm x 135cm
Philips Image Guided Therapy Corporation
AB35SX050200135
In Commercial Distribution

  • 00810060550281 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 200 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050200135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550274

5mm x 200mm x 80cm
Philips Image Guided Therapy Corporation
AB35SX050200080
In Commercial Distribution

  • 00810060550274 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 200 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050200080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550267

5mm x 150mm x 135cm
Philips Image Guided Therapy Corporation
AB35SX050150135
In Commercial Distribution

  • 00810060550267 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 150 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050150135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550250

5mm x 150mm x 80cm
Philips Image Guided Therapy Corporation
AB35SX050150080
In Commercial Distribution

  • 00810060550250 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 150 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050150080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550243

5mm x 120mm x 135cm
Philips Image Guided Therapy Corporation
AB35SX050120135
In Commercial Distribution

  • 00810060550243 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050120135

  • Peripheral angioplasty balloon catheter, drug-coated
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