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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 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 7X80MMX75CM
LUTONIX, INC.
LX18757805F
In Commercial Distribution

  • 00801741177170 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
LX18757805F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X40MMX75CM
LUTONIX, INC.
LX18757405F
In Commercial Distribution

  • 00801741177156 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
LX18757405F

  • 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
LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X80MMX75CM
LUTONIX, INC.
LX18754804F
In Commercial Distribution

  • 00801741176968 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 80 Millimeter
LX18754804F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X60MMX75CM
LUTONIX, INC.
LX18754604F
In Commercial Distribution

  • 00801741176951 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
LX18754604F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 018 4X40MMX75CM
LUTONIX, INC.
LX18754404F
In Commercial Distribution

  • 00801741176944 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 40 Millimeter
LX18754404F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 7mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513072205F
In Commercial Distribution

  • 00801741163470 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX3513072205F

  • Peripheral angioplasty balloon catheter, drug-coated
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