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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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Lutonix® AV Drug Coated Balloon PTA Catheter 4x40x40
LUTONIX, INC.
LX3540440V
Not in Commercial Distribution

  • 00801741135057 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Length, 40 millimeter
LX3540440V

  • Peripheral angioplasty balloon catheter, drug-coated
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 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 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
Lutonix 018 7X120MMX150CM
LUTONIX, INC.
LX1815071205F
In Commercial Distribution

  • 00801741199448 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 120 millimeter
LX1815071205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X100MMX150CM
LUTONIX, INC.
LX1815071005F
In Commercial Distribution

  • 00801741199431 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
LX1815071005F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X80MMX150CM
LUTONIX, INC.
LX181507805F
In Commercial Distribution

  • 00801741199424 ()

  • Balloon Length, 80 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
LX181507805F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X60MMX150CM
LUTONIX, INC.
LX181507605F
In Commercial Distribution

  • 00801741199417 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 150 centimeter
LX181507605F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X40MMX150CM
LUTONIX, INC.
LX181507405F
In Commercial Distribution

  • 00801741199400 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
LX181507405F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 6X220MMX150CM
LUTONIX, INC.
LX1815062205F
In Commercial Distribution

  • 00801741199394 ()

  • Balloon Length, 220 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 6 millimeter
LX1815062205F

  • Peripheral angioplasty balloon catheter, drug-coated
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