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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 - 00801741199424

Lutonix 018 7X80MMX150CM
LUTONIX, INC.
LX181507805F
In Commercial Distribution

  • 00801741199424 ()

  • Balloon Length, 80 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
LX181507805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199417

Lutonix 018 7X60MMX150CM
LUTONIX, INC.
LX181507605F
In Commercial Distribution

  • 00801741199417 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 150 centimeter
LX181507605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199400

Lutonix 018 7X40MMX150CM
LUTONIX, INC.
LX181507405F
In Commercial Distribution

  • 00801741199400 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
LX181507405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199394

Lutonix 018 6X220MMX150CM
LUTONIX, INC.
LX1815062205F
In Commercial Distribution

  • 00801741199394 ()

  • Balloon Length, 220 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 6 millimeter
LX1815062205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199387

Lutonix 018 6X150MMX150CM
LUTONIX, INC.
LX1815061505F
In Commercial Distribution

  • 00801741199387 ()

  • Balloon Length, 150 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 6 millimeter
LX1815061505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199370

Lutonix 018 6X120MMX150CM
LUTONIX, INC.
LX1815061205F
In Commercial Distribution

  • 00801741199370 ()

  • Balloon Length, 120 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 6 millimeter
LX1815061205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199363

Lutonix 018 6X100MMX150CM
LUTONIX, INC.
LX1815061005F
In Commercial Distribution

  • 00801741199363 ()

  • Balloon Diameter, 6 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Length, 100 millimeter
LX1815061005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199356

Lutonix 018 6X80MMX150CM
LUTONIX, INC.
LX181506805F
In Commercial Distribution

  • 00801741199356 ()

  • Catheter Length, 150 centimeter
  • Balloon Length, 80 millimeter
  • Balloon Diameter, 6 millimeter
LX181506805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199349

Lutonix 018 6X60MMX150CM
LUTONIX, INC.
LX181506605F
In Commercial Distribution

  • 00801741199349 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 6 millimeter
  • Balloon Length, 60 millimeter
LX181506605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199332

Lutonix 018 6X40MMX150CM
LUTONIX, INC.
LX181506405F
In Commercial Distribution

  • 00801741199332 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 6 millimeter
LX181506405F

  • Peripheral angioplasty balloon catheter, drug-coated
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