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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 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
Lutonix® AV Drug Coated Balloon PTA Catheter 6x100x100
LUTONIX, INC.
LX351006100V
Not in Commercial Distribution

  • 00801741135668 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 100 millimeter
  • Catheter Length, 100 centimeter
LX351006100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x80x100
LUTONIX, INC.
LX35100680V
Not in Commercial Distribution

  • 00801741135651 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 6 millimeter
  • Balloon Length, 80 millimeter
LX35100680V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x60x100
LUTONIX, INC.
LX35100660V
Not in Commercial Distribution

  • 00801741135644 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 6 millimeter
LX35100660V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x40x100
LUTONIX, INC.
LX35100640V
Not in Commercial Distribution

  • 00801741135637 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
LX35100640V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x100x100
LUTONIX, INC.
LX351005100V
Not in Commercial Distribution

  • 00801741135620 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length,100 millimeter
LX351005100V

  • Peripheral angioplasty balloon catheter, drug-coated
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