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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 - 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

Stellarex - 00813132024987

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 100mm) x 80cm
Spectranetics Corporation
AB35SX050100080
In Commercial Distribution

  • 00813132024987 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050100080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132024970

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 100mm) x 80cm
Spectranetics Corporation
AB35SX040100080
In Commercial Distribution

  • 00813132024970 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040100080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132024291

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 60mm) x 135cm
Spectranetics Corporation
AB35SX060060135
In Commercial Distribution

  • 00813132024291 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 60 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060060135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132024284

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

  • 00813132024284 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132024277

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 60mm) x 135cm
Spectranetics Corporation
AB35SX040060135
In Commercial Distribution

  • 00813132024277 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132024260

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 60mm) x 80cm
Spectranetics Corporation
AB35SX060060080
In Commercial Distribution

  • 00813132024260 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132024253

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

  • 00813132024253 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132024246

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 60mm) x 80cm
Spectranetics Corporation
AB35SX040060080
In Commercial Distribution

  • 00813132024246 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023256

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 120mm) x 135cm
Spectranetics Corporation
AB35SX060120135
In Commercial Distribution

  • 00813132023256 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060120135

  • Peripheral angioplasty balloon catheter, drug-coated
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