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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 - 00801741177729

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X60MMX130CM
LUTONIX, INC.
LX181307605F
In Commercial Distribution

  • 00801741177729 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
LX181307605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177705

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX130CM
LUTONIX, INC.
LX1813062205F
In Commercial Distribution

  • 00801741177705 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 220 Millimeter
LX1813062205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177682

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX130CM
LUTONIX, INC.
LX1813061205F
In Commercial Distribution

  • 00801741177682 ()

  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX1813061205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177668

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X80MMX130CM
LUTONIX, INC.
LX181306805F
In Commercial Distribution

  • 00801741177668 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX181306805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177644

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X40MMX130CM
LUTONIX, INC.
LX181306405F
In Commercial Distribution

  • 00801741177644 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
LX181306405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177620

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX130CM
LUTONIX, INC.
LX1813051505F
In Commercial Distribution

  • 00801741177620 ()

  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX1813051505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177613

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX130CM
LUTONIX, INC.
LX1813051205F
In Commercial Distribution

  • 00801741177613 ()

  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX1813051205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177606

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X100MMX130CM
LUTONIX, INC.
LX1813051005F
In Commercial Distribution

  • 00801741177606 ()

  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
LX1813051005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177590

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X80MMX130CM
LUTONIX, INC.
LX181305805F
In Commercial Distribution

  • 00801741177590 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 80 Millimeter
LX181305805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177583

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X60MMX130CM
LUTONIX, INC.
LX181305605F
In Commercial Distribution

  • 00801741177583 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
LX181305605F

  • Peripheral angioplasty balloon catheter, drug-coated
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