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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® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm 5 French
LUTONIX, INC.
LX351307405F
In Commercial Distribution

  • 00801741123313 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
LX351307405F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm 5 French
LUTONIX, INC.
LX3513061505F
In Commercial Distribution

  • 00801741123306 ()

  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX3513061505F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm 5 French
LUTONIX, INC.
LX3513061205F
In Commercial Distribution

  • 00801741123290 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 6 Millimeter
LX3513061205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x100mm 5 French
LUTONIX, INC.
LX3513061005F
In Commercial Distribution

  • 00801741123283 ()

  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
LX3513061005F

  • Peripheral angioplasty balloon catheter, drug-coated
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® 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® 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® 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® 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® 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
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