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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 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
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 150mm) x 135cm
Spectranetics Corporation
AB35SX050150135
In Commercial Distribution

  • 00813132026950 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 150mm) x 80cm
Spectranetics Corporation
AB35SX040150080
In Commercial Distribution

  • 00813132026707 ()

  • Catheter Length: 80 Centimeter
  • Balloon Length: 150 Millimeter
  • Balloon Diameter: 4 Millimeter
AB35SX040150080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 200mm) x 80cm
Spectranetics Corporation
AB35SX040200080
In Commercial Distribution

  • 00813132026691 ()

  • Catheter Length: 80 Centimeter
  • Balloon Length: 200 Millimeter
  • Balloon Diameter: 4 Millimeter
AB35SX040200080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 150mm) x 80cm
Spectranetics Corporation
AB35SX050150080
In Commercial Distribution

  • 00813132026622 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 200mm) x 80cm
Spectranetics Corporation
AB35SX050200080
In Commercial Distribution

  • 00813132026615 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 150mm) x 80cm
Spectranetics Corporation
AB35SX060150080
In Commercial Distribution

  • 00813132026547 ()

  • Catheter Length: 80 Centimeter
  • Balloon Length: 150 Millimeter
  • Balloon Diameter: 6 Millimeter
AB35SX060150080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 100mm) x 135cm
Spectranetics Corporation
AB35SX060100135
In Commercial Distribution

  • 00813132025021 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060100135

  • Peripheral angioplasty balloon catheter, drug-coated
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
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 100mm) x 135cm
Spectranetics Corporation
AB35SX040100135
In Commercial Distribution

  • 00813132025007 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040100135

  • Peripheral angioplasty balloon catheter, drug-coated
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