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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 - 00813132029036

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 - 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 - 00813132029012

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

  • 00813132029012 ()

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

  • 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 - 00813132028992

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

  • 00813132028992 ()

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

  • 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 - 00813132028978

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX060040135
In Commercial Distribution

  • 00813132028978 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060040135

  • 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 - 00813132028954

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX050080135
In Commercial Distribution

  • 00813132028954 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050080135

  • 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
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