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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 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 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 60mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX040060135
In Commercial Distribution

  • 00813132029036 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 60 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040060135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 60mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX060060080
In Commercial Distribution

  • 00813132029029 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 60 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060060080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 60mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX040060080
In Commercial Distribution

  • 00813132029005 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 60 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040060080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 80mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX040080135
In Commercial Distribution

  • 00813132028923 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040080135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 120mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX060120080
In Commercial Distribution

  • 00813132028909 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060120080

  • Peripheral angioplasty balloon catheter, drug-coated
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 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 200mm) x 135cm
Spectranetics Corporation
AB35SX060200135
In Commercial Distribution

  • 00813132026981 ()

  • Catheter Length: 135 Centimeter
  • Balloon Length: 200 Millimeter
  • Balloon Diameter: 6 Millimeter
AB35SX060200135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 150mm) x 135cm
Spectranetics Corporation
AB35SX060150135
In Commercial Distribution

  • 00813132026974 ()

  • Catheter Length: 135 Centimeter
  • Balloon Length: 150 Millimeter
  • Balloon Diameter: 6 Millimeter
AB35SX060150135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 200mm) x 135cm
Spectranetics Corporation
AB35SX050200135
In Commercial Distribution

  • 00813132026967 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated
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