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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" 75cm 4x100mm 5 French
LUTONIX, INC.
LX357541005F
Not in Commercial Distribution

  • 00801741122767 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 4 Millimeter
LX357541005F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x80mm 5 French
LUTONIX, INC.
LX35754805F
Not in Commercial Distribution

  • 00801741122750 ()

  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 80 Millimeter
  • Catheter Length, 75 Centimeter
LX35754805F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm 5 French
LUTONIX, INC.
LX35754605F
Not in Commercial Distribution

  • 00801741122743 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 60 Millimeter
LX35754605F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm 5 French
LUTONIX, INC.
LX35754405F
Not in Commercial Distribution

  • 00801741122736 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
LX35754405F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x150mm
LUTONIX, INC.
BSCLX351304150
Not in Commercial Distribution

  • 00801741105005 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
BSCLX351304150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x120mm
LUTONIX, INC.
BSCLX351305120
Not in Commercial Distribution

  • 00801741104985 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX351305120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x150mm
LUTONIX, INC.
LX351307150
Not in Commercial Distribution

  • 00801741088773 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX351307150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm
LUTONIX, INC.
LX351306150
Not in Commercial Distribution

  • 00801741088766 ()

  • Balloon Diameter
  • Balloon Length
  • Catheter Length
LX351306150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x150mm
LUTONIX, INC.
LX351305150
Not in Commercial Distribution

  • 00801741088759 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
LX351305150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x150mm
LUTONIX, INC.
LX351304150
Not in Commercial Distribution

  • 00801741088742 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
LX351304150

  • Peripheral angioplasty balloon catheter, drug-coated
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