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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 6x150mm
LUTONIX, INC.
BSCLX351306150
Not in Commercial Distribution

  • 00801741105029 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX351306150

  • 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® AV Drug Coated Balloon PTA Catheter 12x20x100
LUTONIX, INC.
LX351001220V
In Commercial Distribution

  • 00801741135781 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 12 millimeter
  • Balloon Length, 20 millimeter
LX351001220V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x40x100
LUTONIX, INC.
LX351001040V
In Commercial Distribution

  • 00801741135767 ()

  • Balloon Diameter, 10 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
LX351001040V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x60x100
LUTONIX, INC.
LX35100960V
In Commercial Distribution

  • 00801741135743 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 9 millimeter
  • Balloon Length, 60 millimeter
LX35100960V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x20x100
LUTONIX, INC.
LX35100920V
In Commercial Distribution

  • 00801741135729 ()

  • Balloon Length, 20 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 9 millimeter
LX35100920V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x60x100
LUTONIX, INC.
LX35100860V
In Commercial Distribution

  • 00801741135712 ()

  • Balloon Diameter, 8 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
LX35100860V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x40x100
LUTONIX, INC.
LX35100840V
In Commercial Distribution

  • 00801741135705 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 8 millimeter
LX35100840V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x20x100
LUTONIX, INC.
LX35100820V
In Commercial Distribution

  • 00801741135699 ()

  • Catheter Length, 100 centimeter
  • Balloon Length, 20 millimeter
  • Balloon Diameter, 8 millimeter
LX35100820V

  • Peripheral angioplasty balloon catheter, drug-coated
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