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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 - 00801741177255

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X100MMX100CM
LUTONIX, INC.
LX1810041004F
In Commercial Distribution

  • 00801741177255 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 4 Millimeter
LX1810041004F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177248

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X80MMX100CM
LUTONIX, INC.
LX181004804F
In Commercial Distribution

  • 00801741177248 ()

  • Balloon Length, 80 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 4 Millimeter
LX181004804F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177231

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X60MMX100CM
LUTONIX, INC.
LX181004604F
In Commercial Distribution

  • 00801741177231 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 60 Millimeter
LX181004604F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177224

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® Drug Coated Balloon - 00801741177217

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® Drug Coated Balloon - 00801741177200

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® Drug Coated Balloon - 00801741177194

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® Drug Coated Balloon - 00801741177187

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® Drug Coated Balloon - 00801741177170

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® Drug Coated Balloon - 00801741177163

LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X60MMX75CM
LUTONIX, INC.
LX18757605F
In Commercial Distribution

  • 00801741177163 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 60 Millimeter
LX18757605F

  • Peripheral angioplasty balloon catheter, drug-coated
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