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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® Drug Coated Balloon - 00801741177187

LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X100MMX75CM
LUTONIX, INC.
LX187571005F
In Commercial Distribution

  • 00801741177187 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
LX187571005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177170

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® Drug Coated Balloon - 00801741177163

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® Drug Coated Balloon - 00801741177156

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

LUTONIX® Drug Coated Balloon - 00801741177149

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X220MMX75CM
LUTONIX, INC.
LX187562205F
In Commercial Distribution

  • 00801741177149 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 220 Millimeter
LX187562205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177132

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X150MMX75CM
LUTONIX, INC.
LX187561505F
In Commercial Distribution

  • 00801741177132 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 6 Millimeter
LX187561505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177125

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX75CM
LUTONIX, INC.
LX187561205F
In Commercial Distribution

  • 00801741177125 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 120 Millimeter
LX187561205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177118

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X100MMX75CM
LUTONIX, INC.
LX187561005F
In Commercial Distribution

  • 00801741177118 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 100 Millimeter
LX187561005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177101

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X80MMX75CM
LUTONIX, INC.
LX18756805F
In Commercial Distribution

  • 00801741177101 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 80 Millimeter
LX18756805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177095

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X60MMX75CM
LUTONIX, INC.
LX18756605F
In Commercial Distribution

  • 00801741177095 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 6 Millimeter
LX18756605F

  • Peripheral angioplasty balloon catheter, drug-coated
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