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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® AV Drug Coated Balloon PTA Catheter 6x100x75
LUTONIX, INC.
LX35756100V
In Commercial Distribution

  • 00801741135415 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 6 millimeter
LX35756100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x80x40
LUTONIX, INC.
LX3540580V
Not in Commercial Distribution

  • 00801741135118 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 80 millimeter
LX3540580V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x60x40
LUTONIX, INC.
LX3540560V
Not in Commercial Distribution

  • 00801741135101 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length, 40 centimeter
LX3540560V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x40x40
LUTONIX, INC.
LX3540540V
Not in Commercial Distribution

  • 00801741135095 ()

  • Balloon Length, 40 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length, 40 centimeter
LX3540540V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x100x40
LUTONIX, INC.
LX35404100V
Not in Commercial Distribution

  • 00801741135088 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Length, 100 millimeter
LX35404100V

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x220mm
LUTONIX, INC.
LX351307220
Not in Commercial Distribution

  • 00801741178740 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX351307220

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 6x220mm
LUTONIX, INC.
LX351306220
Not in Commercial Distribution

  • 00801741178733 ()

  • Balloon Length, 220 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
LX351306220

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X220MMX130CM
LUTONIX, INC.
LX1813072205F
In Commercial Distribution

  • 00801741177774 ()

  • Balloon Diameter, 7 Milimeter
  • Balloon Length, 220 Millimeter
  • Catheter Length, 130 Centimeter
LX1813072205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X150MMX130CM
LUTONIX, INC.
LX1813071505F
In Commercial Distribution

  • 00801741177767 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX1813071505F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X120MMX130CM
LUTONIX, INC.
LX1813071205F
In Commercial Distribution

  • 00801741177750 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
LX1813071205F

  • Peripheral angioplasty balloon catheter, drug-coated
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