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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 4x80x100
LUTONIX, INC.
LX35100480V
Not in Commercial Distribution

  • 00801741135576 ()

  • Balloon Length, 80 millimeter
  • Balloon Diameter, 4 millimeter
  • Catheter Length, 100 centimeter
LX35100480V

  • 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 4x40x100
LUTONIX, INC.
LX35100440V
Not in Commercial Distribution

  • 00801741135552 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
LX35100440V

  • 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 12x20x75
LUTONIX, INC.
LX35751220V
In Commercial Distribution

  • 00801741135538 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 12 millimeter
  • Balloon Length, 20 millimeter
LX35751220V

  • 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 10x40x75
LUTONIX, INC.
LX35751040V
In Commercial Distribution

  • 00801741135514 ()

  • Balloon Diameter, 10 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
LX35751040V

  • 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 9x40x75
LUTONIX, INC.
LX3575940V
In Commercial Distribution

  • 00801741135484 ()

  • Catheter Length, 75 centimeter
  • Balloon Length, 40 millimeter
  • Balloon Diameter, 9 millimeter
LX3575940V

  • Peripheral angioplasty balloon catheter, drug-coated
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