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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 - 00801741123177

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x120mm 5 French
LUTONIX, INC.
LX3513041205F
In Commercial Distribution

  • 00801741123177 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 4 Millimeter
LX3513041205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123160

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x100mm 5 French
LUTONIX, INC.
LX3513041005F
In Commercial Distribution

  • 00801741123160 ()

  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
LX3513041005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123153

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x80mm 5 French
LUTONIX, INC.
LX351304805F
In Commercial Distribution

  • 00801741123153 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX351304805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123146

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x60mm 5 French
LUTONIX, INC.
LX351304605F
In Commercial Distribution

  • 00801741123146 ()

  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX351304605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123139

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x40mm 5 French
LUTONIX, INC.
LX351304405F
In Commercial Distribution

  • 00801741123139 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
LX351304405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122910

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x150mm 5 French
LUTONIX, INC.
LX357561505F
In Commercial Distribution

  • 00801741122910 ()

  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 150 millimeter
LX357561505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122903

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x120mm 5 French
LUTONIX, INC.
LX357561205F
In Commercial Distribution

  • 00801741122903 ()

  • Catheter Length, 75 centimeter
  • Balloon Length, 120 millimeter
  • Balloon Diameter, 6 millimeter
LX357561205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122897

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x100mm 5 French
LUTONIX, INC.
LX357561005F
Not in Commercial Distribution

  • 00801741122897 ()

  • Balloon Length, 100 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
LX357561005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122880

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm 5 French
LUTONIX, INC.
LX35756805F
Not in Commercial Distribution

  • 00801741122880 ()

  • Balloon Length, 80 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
LX35756805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122873

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm 5 French
LUTONIX, INC.
LX35756605F
Not in Commercial Distribution

  • 00801741122873 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
LX35756605F

  • Peripheral angioplasty balloon catheter, drug-coated
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