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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 018 7X120MMX100CM
LUTONIX, INC.
LX1810071205F
In Commercial Distribution

  • 00801741177477 ()

  • Balloon Diameter, 7 Milimeter
  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
LX1810071205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X150MMX100CM
LUTONIX, INC.
LX1810061505F
In Commercial Distribution

  • 00801741177415 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
LX1810061505F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX100CM
LUTONIX, INC.
LX1810061205F
In Commercial Distribution

  • 00801741177408 ()

  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
LX1810061205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X80MMX100CM
LUTONIX, INC.
LX181006805F
In Commercial Distribution

  • 00801741177385 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 80 Millimeter
LX181006805F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X40MMX100CM
LUTONIX, INC.
LX181006405F
In Commercial Distribution

  • 00801741177361 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
LX181006405F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX100CM
LUTONIX, INC.
LX1810051505F
In Commercial Distribution

  • 00801741177347 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 5 Millimeter
LX1810051505F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX100CM
LUTONIX, INC.
LX1810051205F
In Commercial Distribution

  • 00801741177330 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
LX1810051205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X100MMX100CM
LUTONIX, INC.
LX1810051005F
In Commercial Distribution

  • 00801741177323 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 5 Millimeter
LX1810051005F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X80MMX100CM
LUTONIX, INC.
LX181005805F
In Commercial Distribution

  • 00801741177316 ()

  • Balloon Length, 80 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
LX181005805F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X60MMX100CM
LUTONIX, INC.
LX181005605F
In Commercial Distribution

  • 00801741177309 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 60 Millimeter
LX181005605F

  • Peripheral angioplasty balloon catheter, drug-coated
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