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 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 6X100MMX100CM
LUTONIX, INC.
LX1810061005F
In Commercial Distribution

  • 00801741177392 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 100 Millimeter
LX1810061005F

  • 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 6X60MMX100CM
LUTONIX, INC.
LX181006605F
In Commercial Distribution

  • 00801741177378 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Length, 60 Millimeter
LX181006605F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X220MMX100CM
LUTONIX, INC.
LX1810052205F
In Commercial Distribution

  • 00801741177354 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 220 Millimeter
LX1810052205F

  • 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 7X80MMX75CM
LUTONIX, INC.
LX18757805F
In Commercial Distribution

  • 00801741177170 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
LX18757805F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X60MMX75CM
LUTONIX, INC.
LX18757605F
In Commercial Distribution

  • 00801741177163 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 60 Millimeter
LX18757605F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X40MMX75CM
LUTONIX, INC.
LX18757405F
In Commercial Distribution

  • 00801741177156 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
LX18757405F

  • Peripheral angioplasty balloon catheter, drug-coated
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