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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 - 00801741123269

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x60mm 5 French
LUTONIX, INC.
LX351306605F
In Commercial Distribution

  • 00801741123269 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 60 Millimeter
LX351306605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123252

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x40mm 5 French
LUTONIX, INC.
LX351306405F
In Commercial Distribution

  • 00801741123252 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
LX351306405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123245

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x150mm 5 French
LUTONIX, INC.
LX3513051505F
In Commercial Distribution

  • 00801741123245 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX3513051505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123238

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x120mm 5 French
LUTONIX, INC.
LX3513051205F
In Commercial Distribution

  • 00801741123238 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
LX3513051205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123221

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x100mm 5 French
LUTONIX, INC.
LX3513051005F
In Commercial Distribution

  • 00801741123221 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 100 Millimeter
LX3513051005F

  • Peripheral angioplasty balloon catheter, drug-coated

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
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