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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 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 5x60x100
LUTONIX, INC.
LX35100560V
Not in Commercial Distribution

  • 00801741135606 ()

  • Balloon Diameter, 5 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
LX35100560V

  • Peripheral angioplasty balloon catheter, drug-coated
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 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 8x20x75
LUTONIX, INC.
LX3575820V
In Commercial Distribution

  • 00801741135446 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 8millimeter
  • Catheter Length, 75 centimeter
LX3575820V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 7x40x75
LUTONIX, INC.
LX3575740V
In Commercial Distribution

  • 00801741135422 ()

  • Balloon Diameter, 7 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 40 millimeter
LX3575740V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x100x75
LUTONIX, INC.
LX35756100V
In Commercial Distribution

  • 00801741135415 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 6 millimeter
LX35756100V

  • Peripheral angioplasty balloon catheter, drug-coated
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