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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 8x60x40
LUTONIX, INC.
LX3540860V
In Commercial Distribution

  • 00801741135217 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 8 millimeter
  • Balloon Length, 60 millimeter
LX3540860V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x20x40
LUTONIX, INC.
LX3540820V
In Commercial Distribution

  • 00801741135194 ()

  • Balloon Length, 20 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Diameter, 8 millimeter
LX3540820V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 7x40x40
LUTONIX, INC.
LX3540740V
In Commercial Distribution

  • 00801741135170 ()

  • Balloon Length, 40 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 40 centimeter
LX3540740V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x80x40
LUTONIX, INC.
LX3540680V
Not in Commercial Distribution

  • 00801741135156 ()

  • Catheter Length, 40 centimeter
  • Balloon Length, 80 millimeter
  • Balloon Diameter, 6 millimeter
LX3540680V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x60x40
LUTONIX, INC.
LX3540660V
Not in Commercial Distribution

  • 00801741135149 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Diameter, 6 millimeter
LX3540660V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x100x40
LUTONIX, INC.
LX35405100V
Not in Commercial Distribution

  • 00801741135125 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 100 millimeter
LX35405100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x40x40
LUTONIX, INC.
LX3540540V
Not in Commercial Distribution

  • 00801741135095 ()

  • Balloon Length, 40 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length, 40 centimeter
LX3540540V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x60x40
LUTONIX, INC.
LX3540460V
Not in Commercial Distribution

  • 00801741135064 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 60 millimeter
LX3540460V

  • Peripheral angioplasty balloon catheter, drug-coated
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 Drug Coated Balloon PTA Catheter .035" 130cm 6X80mm 5 French
LUTONIX, INC.
LX351306805F
In Commercial Distribution

  • 00801741126888 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 80 Millimeter
LX351306805F

  • Peripheral angioplasty balloon catheter, drug-coated
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