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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 - 00801741177392

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X100MMX100CM
LUTONIX, INC.
LX1810061005F
In Commercial Distribution

  • 00801741177392 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 100 Millimeter
LX1810061005F

  • 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 - 00801741177378

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X60MMX100CM
LUTONIX, INC.
LX181006605F
In Commercial Distribution

  • 00801741177378 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Length, 60 Millimeter
LX181006605F

  • 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 - 00801741177354

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X220MMX100CM
LUTONIX, INC.
LX1810052205F
In Commercial Distribution

  • 00801741177354 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 220 Millimeter
LX1810052205F

  • 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

LUTONIX® Drug Coated Balloon - 00801741177330

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX100CM
LUTONIX, INC.
LX1810051205F
In Commercial Distribution

  • 00801741177330 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
LX1810051205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177323

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X100MMX100CM
LUTONIX, INC.
LX1810051005F
In Commercial Distribution

  • 00801741177323 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 5 Millimeter
LX1810051005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177316

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X80MMX100CM
LUTONIX, INC.
LX181005805F
In Commercial Distribution

  • 00801741177316 ()

  • Balloon Length, 80 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
LX181005805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177309

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X60MMX100CM
LUTONIX, INC.
LX181005605F
In Commercial Distribution

  • 00801741177309 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 60 Millimeter
LX181005605F

  • Peripheral angioplasty balloon catheter, drug-coated
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