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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 - 00801741122750

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® Drug Coated Balloon - 00801741122743

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® Drug Coated Balloon - 00801741122736

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® Drug Coated Balloon - 00801741109454

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm
LUTONIX, INC.
BSCLX35130760
Not in Commercial Distribution

  • 00801741109454 ()

  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
BSCLX35130760

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741109447

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm
LUTONIX, INC.
BSCLX35130740
Not in Commercial Distribution

  • 00801741109447 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
BSCLX35130740

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741109430

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x60mm
LUTONIX, INC.
BSCLX3575760
Not in Commercial Distribution

  • 00801741109430 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
BSCLX3575760

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741109423

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x40mm
LUTONIX, INC.
BSCLX3575740
Not in Commercial Distribution

  • 00801741109423 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 75 Centimeter
BSCLX3575740

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741105081

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x150mm
LUTONIX, INC.
BSCLX35756150
In Commercial Distribution

  • 00801741105081 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
BSCLX35756150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741105074

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x150mm
LUTONIX, INC.
BSCLX35755150
In Commercial Distribution

  • 00801741105074 ()

  • Balloon Diameter
  • Balloon Length
  • Catheter Length
BSCLX35755150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741105067

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x150mm
LUTONIX, INC.
BSCLX35754150
In Commercial Distribution

  • 00801741105067 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
BSCLX35754150

  • Peripheral angioplasty balloon catheter, drug-coated
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