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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 - 00813132029050

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

  • 00813132029050 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132029029

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 - 00813132029005

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 - 00813132028985

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX060080135
In Commercial Distribution

  • 00813132028985 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060080135

  • 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 - 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 - 00813132028916

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX040040135
In Commercial Distribution

  • 00813132028916 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040040135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028893

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX060080080
In Commercial Distribution

  • 00813132028893 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060080080

  • 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

Stellarex - 00813132028831

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 80mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX040080080
In Commercial Distribution

  • 00813132028831 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040080080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028824

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX040040080
In Commercial Distribution

  • 00813132028824 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040040080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028800

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

  • 00813132028800 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028787

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

  • 00813132028787 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028763

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 100mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX060100135
In Commercial Distribution

  • 00813132028763 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026981

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 - 00813132026974

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 - 00813132026967

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 - 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 - 00813132026530

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 200mm) x 80cm
Spectranetics Corporation
AB35SX060200080
In Commercial Distribution

  • 00813132026530 ()

  • Catheter Length: 80 Centimeter
  • Balloon Length: 200 Millimeter
  • Balloon Diameter: 6 Millimeter
AB35SX060200080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026462

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 150mm) x 135cm
Spectranetics Corporation
AB35SX040150135
In Commercial Distribution

  • 00813132026462 ()

  • Catheter Length: 135 Centimeter
  • Balloon Length: 150 Millimeter
  • Balloon Diameter: 4 Millimeter
AB35SX040150135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026455

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 200mm) x 135cm
Spectranetics Corporation
AB35SX040200135
In Commercial Distribution

  • 00813132026455 ()

  • Catheter Length: 135 Centimeter
  • Balloon Length: 200 Millimeter
  • Balloon Diameter: 4 Millimeter
AB35SX040200135

  • 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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