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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 - 00813132026950

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 - 00813132026707

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 - 00813132026691

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 - 00813132026622

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 - 00813132026615

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 - 00813132026547

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 - 00813132025021

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 - 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

Stellarex - 00813132025007

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

Stellarex - 00813132024994

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 100mm) x 80cm
Spectranetics Corporation
AB35SX060100080
In Commercial Distribution

  • 00813132024994 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060100080

  • Peripheral angioplasty balloon catheter, drug-coated
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