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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 - 00801741177545

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X120MMX130CM
LUTONIX, INC.
LX1813041204F
In Commercial Distribution

  • 00801741177545 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
LX1813041204F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177538

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X100MMX130CM
LUTONIX, INC.
LX1813041004F
In Commercial Distribution

  • 00801741177538 ()

  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX1813041004F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177521

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X80MMX130CM
LUTONIX, INC.
LX181304804F
In Commercial Distribution

  • 00801741177521 ()

  • Balloon Length, 80 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
LX181304804F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177514

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X60MMX130CM
LUTONIX, INC.
LX181304604F
In Commercial Distribution

  • 00801741177514 ()

  • Balloon Length, 60 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
LX181304604F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177507

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X40MMX130CM
LUTONIX, INC.
LX181304404F
In Commercial Distribution

  • 00801741177507 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 4 Millimeter
LX181304404F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177491

Lutonix 018 7X220MMX100CM
LUTONIX, INC.
LX1810072205F
In Commercial Distribution

  • 00801741177491 ()

  • Balloon Length, 220 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 7 Millimeter
LX1810072205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177484

Lutonix 018 7X150MMX100CM
LUTONIX, INC.
LX1810071505F
In Commercial Distribution

  • 00801741177484 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 7 Millimeter
LX1810071505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177477

Lutonix 018 7X120MMX100CM
LUTONIX, INC.
LX1810071205F
In Commercial Distribution

  • 00801741177477 ()

  • Balloon Diameter, 7 Milimeter
  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
LX1810071205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177460

Lutonix 018 7X100MMX100CM
LUTONIX, INC.
LX1810071005F
In Commercial Distribution

  • 00801741177460 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
LX1810071005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® Drug Coated Balloon - 00801741177453

Lutonix 018 7X80MMX100CM
LUTONIX, INC.
LX181007805F
In Commercial Distribution

  • 00801741177453 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 100 Centimeter
LX181007805F

  • Peripheral angioplasty balloon catheter, drug-coated
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