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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 - 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 - 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 - 00801741177415

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X150MMX100CM
LUTONIX, INC.
LX1810061505F
In Commercial Distribution

  • 00801741177415 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
LX1810061505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177408

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX100CM
LUTONIX, INC.
LX1810061205F
In Commercial Distribution

  • 00801741177408 ()

  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
LX1810061205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177385

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X80MMX100CM
LUTONIX, INC.
LX181006805F
In Commercial Distribution

  • 00801741177385 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 80 Millimeter
LX181006805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177361

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X40MMX100CM
LUTONIX, INC.
LX181006405F
In Commercial Distribution

  • 00801741177361 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
LX181006405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177347

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX100CM
LUTONIX, INC.
LX1810051505F
In Commercial Distribution

  • 00801741177347 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 5 Millimeter
LX1810051505F

  • Peripheral angioplasty balloon catheter, drug-coated
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