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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 10x60x100
LUTONIX, INC.
LX351001060V
In Commercial Distribution

  • 00801741135774 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 10 millimeter
LX351001060V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x40x100
LUTONIX, INC.
LX351001040V
In Commercial Distribution

  • 00801741135767 ()

  • Balloon Diameter, 10 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
LX351001040V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x100
LUTONIX, INC.
LX351001020V
In Commercial Distribution

  • 00801741135750 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 10 millimeter
  • Balloon Length, 20 millimeter
LX351001020V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x60x100
LUTONIX, INC.
LX35100960V
In Commercial Distribution

  • 00801741135743 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 9 millimeter
  • Balloon Length, 60 millimeter
LX35100960V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x20x100
LUTONIX, INC.
LX35100920V
In Commercial Distribution

  • 00801741135729 ()

  • Balloon Length, 20 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 9 millimeter
LX35100920V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x60x100
LUTONIX, INC.
LX35100860V
In Commercial Distribution

  • 00801741135712 ()

  • Balloon Diameter, 8 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
LX35100860V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x40x100
LUTONIX, INC.
LX35100840V
In Commercial Distribution

  • 00801741135705 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 8 millimeter
LX35100840V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x20x100
LUTONIX, INC.
LX35100820V
In Commercial Distribution

  • 00801741135699 ()

  • Catheter Length, 100 centimeter
  • Balloon Length, 20 millimeter
  • Balloon Diameter, 8 millimeter
LX35100820V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 7x60x100
LUTONIX, INC.
LX35100760V
Not in Commercial Distribution

  • 00801741135682 ()

  • Catheter Length, 100 centimeter
  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
LX35100760V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 7x40x100
LUTONIX, INC.
LX35100740V
Not in Commercial Distribution

  • 00801741135675 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 40 millimeter
LX35100740V

  • Peripheral angioplasty balloon catheter, drug-coated
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