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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® 018 Drug Coated Balloon PTA Catheter, 4X40MMX100CM
LUTONIX, INC.
LX181004404F
In Commercial Distribution

  • 00801741177224 ()

  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 40, Millimeter
  • Catheter Length, 100, Centimeter
LX181004404F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X220MMX75CM
LUTONIX, INC.
LX187572205F
In Commercial Distribution

  • 00801741177217 ()

  • Catheter Length, 75cm
  • Balloon Diameter, 7mm
  • Balloon Length, 220mm
LX187572205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X150MMX75CM
LUTONIX, INC.
LX187571505F
In Commercial Distribution

  • 00801741177200 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 150 Millimeter
LX187571505F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X120MMX75CM
LUTONIX, INC.
LX187571205F
In Commercial Distribution

  • 00801741177194 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 120 Millimeter
  • Catheter Length, 75 Centimeter
LX187571205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X100MMX75CM
LUTONIX, INC.
LX187571005F
In Commercial Distribution

  • 00801741177187 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
LX187571005F

  • Peripheral angioplasty balloon catheter, drug-coated
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® 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® 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® 018 Drug Coated Balloon PTA Catheter 4X220MMX75CM
LUTONIX, INC.
LX187542204F
In Commercial Distribution

  • 00801741177002 ()

  • Balloon Length, 220 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
LX187542204F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X120MMX75CM
LUTONIX, INC.
LX187541204F
In Commercial Distribution

  • 00801741176982 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 120 Millimeter
LX187541204F

  • Peripheral angioplasty balloon catheter, drug-coated
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