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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 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 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 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 8x60x75
LUTONIX, INC.
LX3575860V
In Commercial Distribution

  • 00801741135460 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 8 millimeter
  • Catheter Length, 75 centimeter
LX3575860V

  • 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 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
Lutonix® AV Drug Coated Balloon PTA Catheter 6x60x75
LUTONIX, INC.
LX3575660V
In Commercial Distribution

  • 00801741135392 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter,6 millimeter
LX3575660V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x100x75
LUTONIX, INC.
LX35755100V
In Commercial Distribution

  • 00801741135378 ()

  • Balloon Length, 100 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length,75 centimeter
LX35755100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x80x75
LUTONIX, INC.
LX3575580V
In Commercial Distribution

  • 00801741135361 ()

  • Balloon Diameter,5 millimeter
  • Balloon Length, 80 millimeter
  • Catheter Length, 75 centimeter
LX3575580V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x40x75
LUTONIX, INC.
LX3575540V
In Commercial Distribution

  • 00801741135347 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
LX3575540V

  • Peripheral angioplasty balloon catheter, drug-coated
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