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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 - 00801741123214

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x80mm 5 French
LUTONIX, INC.
LX351305805F
In Commercial Distribution

  • 00801741123214 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX351305805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123207

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x60mm 5 French
LUTONIX, INC.
LX351305605F
In Commercial Distribution

  • 00801741123207 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
LX351305605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123191

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x40mm 5 French
LUTONIX, INC.
LX351305405F
In Commercial Distribution

  • 00801741123191 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX351305405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123184

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x150mm 5 French
LUTONIX, INC.
LX3513041505F
In Commercial Distribution

  • 00801741123184 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
LX3513041505F

  • Peripheral angioplasty balloon catheter, drug-coated

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 - 00801741122934

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x60mm 5 French
LUTONIX, INC.
LX35757605F
In Commercial Distribution

  • 00801741122934 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 7 millimeter
LX35757605F

  • Peripheral angioplasty balloon catheter, drug-coated
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