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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 018 5X80MMX150CM
LUTONIX, INC.
LX181505805F
In Commercial Distribution

  • 00801741199288 ()

  • Balloon Length, 80 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 5 millimeter
LX181505805F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 5X60MMX150CM
LUTONIX, INC.
LX181505605F
In Commercial Distribution

  • 00801741199271 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 5 millimeter
LX181505605F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 5X40MMX150CM
LUTONIX, INC.
LX181505405F
In Commercial Distribution

  • 00801741199264 ()

  • Catheter Length, 150 centimeter
  • Balloon Length, 40 millimeter
  • Balloon Diameter, 5 millimeter
LX181505405F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 5X300MMX130CM
LUTONIX, INC.
LX1813053005F
In Commercial Distribution

  • 00801741184710 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 300 Millimeter
  • Balloon Diameter, 5 Millimeter
LX1813053005F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 5X300MMX100CM
LUTONIX, INC.
LX1810053005F
In Commercial Distribution

  • 00801741184680 ()

  • Balloon Length, 300 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 100 Centimeter
LX1810053005F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X220MMX130CM
LUTONIX, INC.
LX1813052205F
In Commercial Distribution

  • 00801741177637 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 220 Millimeter
LX1813052205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX130CM
LUTONIX, INC.
LX1813051505F
In Commercial Distribution

  • 00801741177620 ()

  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX1813051505F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX130CM
LUTONIX, INC.
LX1813051205F
In Commercial Distribution

  • 00801741177613 ()

  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX1813051205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X100MMX130CM
LUTONIX, INC.
LX1813051005F
In Commercial Distribution

  • 00801741177606 ()

  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
LX1813051005F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X80MMX130CM
LUTONIX, INC.
LX181305805F
In Commercial Distribution

  • 00801741177590 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 80 Millimeter
LX181305805F

  • Peripheral angioplasty balloon catheter, drug-coated
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