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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 - 00813132023140

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX060040080
In Commercial Distribution

  • 00813132023140 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060040080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023133

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX050120080
In Commercial Distribution

  • 00813132023133 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050120080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023126

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 80cm
Spectranetics Corporation
AB35SX050080080
In Commercial Distribution

  • 00813132023126 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050080080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023119

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX050040080
In Commercial Distribution

  • 00813132023119 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050040080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023102

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX040120080
In Commercial Distribution

  • 00813132023102 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040120080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023096

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

  • 00813132023096 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023089

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

  • 00813132023089 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix 035 Drug Coated Balloon PTA Catheter - 00801741202575

Lutonix 035 12X60MMx75CM
LUTONIX, INC.
LX35751260V
In Commercial Distribution

  • 00801741202575 ()

  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 12 Millimeter
  • Catheter Length, 75 Centimeters
LX35751260V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199462

Lutonix 018 7X220MMX150CM
LUTONIX, INC.
LX1815072205F
In Commercial Distribution

  • 00801741199462 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 220 millimeter
LX1815072205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199455

Lutonix 018 7X150MMX150CM
LUTONIX, INC.
LX1815071505F
In Commercial Distribution

  • 00801741199455 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 150 millimeter
LX1815071505F

  • Peripheral angioplasty balloon catheter, drug-coated
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