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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 - 00801741177118

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X100MMX75CM
LUTONIX, INC.
LX187561005F
In Commercial Distribution

  • 00801741177118 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 100 Millimeter
LX187561005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177101

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X80MMX75CM
LUTONIX, INC.
LX18756805F
In Commercial Distribution

  • 00801741177101 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 80 Millimeter
LX18756805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177095

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X60MMX75CM
LUTONIX, INC.
LX18756605F
In Commercial Distribution

  • 00801741177095 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 6 Millimeter
LX18756605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177088

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X40MMX75CM
LUTONIX, INC.
LX18756405F
In Commercial Distribution

  • 00801741177088 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 6 Millimeter
LX18756405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177071

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X220MMX75CM
LUTONIX, INC.
LX187552205F
In Commercial Distribution

  • 00801741177071 ()

  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 220 Millimeter
  • Catheter Length, 75 Centimeter
LX187552205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177064

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X150MMX75CM
LUTONIX, INC.
LX187551505F
In Commercial Distribution

  • 00801741177064 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 150 Millimeter
LX187551505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177057

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX75CM
LUTONIX, INC.
LX187551205F
In Commercial Distribution

  • 00801741177057 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 120 Millimeter
LX187551205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177040

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X100MMX75CM
LUTONIX, INC.
LX187551005F
In Commercial Distribution

  • 00801741177040 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 100 Millimeter
LX187551005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177033

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X80MMX75CM
LUTONIX, INC.
LX18755805F
In Commercial Distribution

  • 00801741177033 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 5 Millimeter
LX18755805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177026

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X60MMX75CM
LUTONIX, INC.
LX18755605F
In Commercial Distribution

  • 00801741177026 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 60 Millimeter
LX18755605F

  • Peripheral angioplasty balloon catheter, drug-coated
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