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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 - 00813132029098

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 200mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX050200080
In Commercial Distribution

  • 00813132029098 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132029081

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 150mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX050150080
In Commercial Distribution

  • 00813132029081 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132029043

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 60mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX050060135
In Commercial Distribution

  • 00813132029043 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 60 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050060135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132029012

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 60mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX050060080
In Commercial Distribution

  • 00813132029012 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 60 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050060080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028961

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX050120135
In Commercial Distribution

  • 00813132028961 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028954

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX050080135
In Commercial Distribution

  • 00813132028954 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050080135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028947

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX050040135
In Commercial Distribution

  • 00813132028947 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050040135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028879

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX050120080
In Commercial Distribution

  • 00813132028879 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050120080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028862

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX050080080
In Commercial Distribution

  • 00813132028862 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050080080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028855

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX050040080
In Commercial Distribution

  • 00813132028855 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050040080

  • Peripheral angioplasty balloon catheter, drug-coated
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