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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 4x100x100
LUTONIX, INC.
LX351004100V
Not in Commercial Distribution

  • 00801741135583 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 4 millimeter
LX351004100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x60x100
LUTONIX, INC.
LX35100460V
Not in Commercial Distribution

  • 00801741135569 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 60 millimeter
LX35100460V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x40x75
LUTONIX, INC.
LX35751240V
In Commercial Distribution

  • 00801741135545 ()

  • Balloon Diameter, 12 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
LX35751240V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x60x75
LUTONIX, INC.
LX35751060V
In Commercial Distribution

  • 00801741135521 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 10 millimeter
  • Balloon Length, 60 millimeter
LX35751060V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x75
LUTONIX, INC.
LX35751020V
In Commercial Distribution

  • 00801741135507 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 10 millimeter
  • Balloon Length, 20 millimeter
LX35751020V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x60x75
LUTONIX, INC.
LX3575960V
In Commercial Distribution

  • 00801741135491 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 9 millimeter
LX3575960V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x20x75
LUTONIX, INC.
LX3575920V
In Commercial Distribution

  • 00801741135477 ()

  • Balloon Diameter, 9 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 20 millimeter
LX3575920V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x40x75
LUTONIX, INC.
LX3575840V
In Commercial Distribution

  • 00801741135453 ()

  • Balloon Diameter, 8 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 40 millimeter
LX3575840V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 7x60x75
LUTONIX, INC.
LX3575760V
In Commercial Distribution

  • 00801741135439 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 60millimeter
LX3575760V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x80x75
LUTONIX, INC.
LX3575680V
In Commercial Distribution

  • 00801741135408 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 80 millimeter
  • Catheter Length, 75 centimeter
LX3575680V

  • Peripheral angioplasty balloon catheter, drug-coated
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