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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 - 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 - 00801741199257

Lutonix 018 4X220MMX150CM
LUTONIX, INC.
LX1815042204F
In Commercial Distribution

  • 00801741199257 ()

  • Balloon Length, 220 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 4 millimeter
LX1815042204F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199240

Lutonix 018 4X150MMX150CM
LUTONIX, INC.
LX1815041504F
In Commercial Distribution

  • 00801741199240 ()

  • Balloon Length, 150 millimeter
  • Balloon Diameter, 4 millimeter
  • Catheter Length, 150 centimeter
LX1815041504F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199233

Lutonix 018 4X120MMX150CM
LUTONIX, INC.
LX1815041204F
In Commercial Distribution

  • 00801741199233 ()

  • Balloon Length, 120 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 4 millimeter
LX1815041204F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199226

Lutonix 018 4X100MMX150CM
LUTONIX, INC.
LX1815041004F
In Commercial Distribution

  • 00801741199226 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 100 millimeter
  • Catheter Length, 150 centimeter
LX1815041004F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199219

Lutonix 018 4X80MMX150CM
LUTONIX, INC.
LX181504804F
In Commercial Distribution

  • 00801741199219 ()

  • Catheter Length, 150 centimeter
  • Balloon Length, 80 millimeter
  • Balloon Diameter, 4 millimeter
LX181504804F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199202

Lutonix 018 4X60MMX150CM
LUTONIX, INC.
LX181504604F
In Commercial Distribution

  • 00801741199202 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Length, 60 millimeter
LX181504604F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199196

Lutonix 018 4X40MMX150CM
LUTONIX, INC.
LX181504404F
In Commercial Distribution

  • 00801741199196 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 40 millimeter
LX181504404F

  • Peripheral angioplasty balloon catheter, drug-coated
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