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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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135231

Lutonix® AV Drug Coated Balloon PTA Catheter 9x40x40
LUTONIX, INC.
LX3540940V
Not in Commercial Distribution

  • 00801741135231 ()

  • Balloon Diameter, 9 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 40 centimeter
LX3540940V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135224

Lutonix® AV Drug Coated Balloon PTA Catheter 9x20x40
LUTONIX, INC.
LX3540920V
In Commercial Distribution

  • 00801741135224 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 9 millimeter
  • Catheter Length, 40 centimeter
LX3540920V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135217

Lutonix® AV Drug Coated Balloon PTA Catheter 8x60x40
LUTONIX, INC.
LX3540860V
In Commercial Distribution

  • 00801741135217 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 8 millimeter
  • Balloon Length, 60 millimeter
LX3540860V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135200

Lutonix® AV Drug Coated Balloon PTA Catheter 8x40x40
LUTONIX, INC.
LX3540840V
In Commercial Distribution

  • 00801741135200 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 8 millimeter
  • Balloon Length, 40 millimeter
LX3540840V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135194

Lutonix® AV Drug Coated Balloon PTA Catheter 8x20x40
LUTONIX, INC.
LX3540820V
In Commercial Distribution

  • 00801741135194 ()

  • Balloon Length, 20 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Diameter, 8 millimeter
LX3540820V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135187

Lutonix® AV Drug Coated Balloon PTA Catheter 7x60x40
LUTONIX, INC.
LX3540760V
In Commercial Distribution

  • 00801741135187 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 40 centimeter
LX3540760V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135170

Lutonix® AV Drug Coated Balloon PTA Catheter 7x40x40
LUTONIX, INC.
LX3540740V
In Commercial Distribution

  • 00801741135170 ()

  • Balloon Length, 40 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 40 centimeter
LX3540740V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135163

Lutonix® AV Drug Coated Balloon PTA Catheter 6x100x40
LUTONIX, INC.
LX35406100V
Not in Commercial Distribution

  • 00801741135163 ()

  • Balloon Length, 100 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 40 centimeter
LX35406100V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135156

Lutonix® AV Drug Coated Balloon PTA Catheter 6x80x40
LUTONIX, INC.
LX3540680V
Not in Commercial Distribution

  • 00801741135156 ()

  • Catheter Length, 40 centimeter
  • Balloon Length, 80 millimeter
  • Balloon Diameter, 6 millimeter
LX3540680V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135149

Lutonix® AV Drug Coated Balloon PTA Catheter 6x60x40
LUTONIX, INC.
LX3540660V
Not in Commercial Distribution

  • 00801741135149 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Diameter, 6 millimeter
LX3540660V

  • Peripheral angioplasty balloon catheter, drug-coated
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