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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 - 00801741199301

Lutonix 018 5X120MMX150CM
LUTONIX, INC.
LX1815051205F
In Commercial Distribution

  • 00801741199301 ()

  • Balloon Diameter, 5 millimeter
  • Balloon Length, 120 millimeter
  • Catheter Length, 150 centimeter
LX1815051205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199295

Lutonix 018 5X100MMX150CM
LUTONIX, INC.
LX1815051005F
In Commercial Distribution

  • 00801741199295 ()

  • Catheter Length, 150 centimeter
  • Balloon Length, 100 millimeter
  • Balloon Diameter, 5 millimeter
LX1815051005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199288

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® Drug Coated Balloon - 00801741199271

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® Drug Coated Balloon - 00801741199264

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® Drug Coated Balloon - 00801741184710

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® Drug Coated Balloon - 00801741184680

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® Drug Coated Balloon - 00801741177637

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® Drug Coated Balloon - 00801741177620

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® Drug Coated Balloon - 00801741177613

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
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