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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® AV Drug Coated Balloon PTA Catheter 9x20x75
LUTONIX, INC.
LX3575920V
In Commercial Distribution

  • 00801741135477 ()

  • Balloon Diameter, 9 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 20 millimeter
LX3575920V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x20x75
LUTONIX, INC.
LX3575820V
In Commercial Distribution

  • 00801741135446 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 8millimeter
  • Catheter Length, 75 centimeter
LX3575820V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 7x40x75
LUTONIX, INC.
LX3575740V
In Commercial Distribution

  • 00801741135422 ()

  • Balloon Diameter, 7 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 40 millimeter
LX3575740V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x100x75
LUTONIX, INC.
LX35756100V
In Commercial Distribution

  • 00801741135415 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 6 millimeter
LX35756100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x80x75
LUTONIX, INC.
LX3575680V
In Commercial Distribution

  • 00801741135408 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 80 millimeter
  • Catheter Length, 75 centimeter
LX3575680V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x60x75
LUTONIX, INC.
LX3575660V
In Commercial Distribution

  • 00801741135392 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter,6 millimeter
LX3575660V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x40x75
LUTONIX, INC.
LX3575640V
In Commercial Distribution

  • 00801741135385 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 6 millimeter
LX3575640V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x100x75
LUTONIX, INC.
LX35755100V
In Commercial Distribution

  • 00801741135378 ()

  • Balloon Length, 100 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length,75 centimeter
LX35755100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x80x75
LUTONIX, INC.
LX3575580V
In Commercial Distribution

  • 00801741135361 ()

  • Balloon Diameter,5 millimeter
  • Balloon Length, 80 millimeter
  • Catheter Length, 75 centimeter
LX3575580V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x60x75
LUTONIX, INC.
LX3575560V
In Commercial Distribution

  • 00801741135354 ()

  • Balloon Diameter, 5 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length,75 centimeter
LX3575560V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x40x75
LUTONIX, INC.
LX3575540V
In Commercial Distribution

  • 00801741135347 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
LX3575540V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x100x75
LUTONIX, INC.
LX35754100V
In Commercial Distribution

  • 00801741135330 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 100 millimeter
LX35754100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x80x75
LUTONIX, INC.
LX3575480V
In Commercial Distribution

  • 00801741135323 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 80 millimeter
LX3575480V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x60x75
LUTONIX, INC.
LX3575460V
In Commercial Distribution

  • 00801741135316 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 60 millimeter
LX3575460V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x40x75
LUTONIX, INC.
LX3575440V
In Commercial Distribution

  • 00801741135309 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 4 millimeter
LX3575440V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x40x40
LUTONIX, INC.
LX35401240V
Not in Commercial Distribution

  • 00801741135293 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Diameter, 12 millimeter
LX35401240V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x40
LUTONIX, INC.
LX35401220V
In Commercial Distribution

  • 00801741135286 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 12 millimeter
  • Catheter Length, 40 centimeter
LX35401220V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x60x40
LUTONIX, INC.
LX35401060V
Not in Commercial Distribution

  • 00801741135279 ()

  • Balloon Diameter, 10 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 40 centimeter
LX35401060V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x40x40
LUTONIX, INC.
LX35401040V
Not in Commercial Distribution

  • 00801741135262 ()

  • Catheter Length, 40 centimeter
  • Balloon Length, 40 millimeter
  • Balloon Diameter, 10 millimeter
LX35401040V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x40
LUTONIX, INC.
LX35401020V
In Commercial Distribution

  • 00801741135255 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 10 millimeter
  • Catheter Length, 40 centimeter
LX35401020V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x60x40
LUTONIX, INC.
LX3540960V
Not in Commercial Distribution

  • 00801741135248 ()

  • Catheter Length, 40 centimeter
  • Balloon Length, 60 millimeter
  • Balloon Diameter, 9 millimeter
LX3540960V

  • Peripheral angioplasty balloon catheter, drug-coated
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® 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® 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® 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® 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® 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® 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® 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® 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® 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
Lutonix® AV Drug Coated Balloon PTA Catheter 6x40x40
LUTONIX, INC.
LX3540640V
Not in Commercial Distribution

  • 00801741135132 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 6 millimeter
  • Balloon Length, 40 millimeter
LX3540640V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x100x40
LUTONIX, INC.
LX35405100V
Not in Commercial Distribution

  • 00801741135125 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 100 millimeter
LX35405100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x80x40
LUTONIX, INC.
LX3540580V
Not in Commercial Distribution

  • 00801741135118 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 80 millimeter
LX3540580V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x60x40
LUTONIX, INC.
LX3540560V
Not in Commercial Distribution

  • 00801741135101 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length, 40 centimeter
LX3540560V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x40x40
LUTONIX, INC.
LX3540540V
Not in Commercial Distribution

  • 00801741135095 ()

  • Balloon Length, 40 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length, 40 centimeter
LX3540540V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x100x40
LUTONIX, INC.
LX35404100V
Not in Commercial Distribution

  • 00801741135088 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Length, 100 millimeter
LX35404100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x80x40
LUTONIX, INC.
LX3540480V
Not in Commercial Distribution

  • 00801741135071 ()

  • Cathether Length, 40 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 80 millimeter
LX3540480V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x60x40
LUTONIX, INC.
LX3540460V
Not in Commercial Distribution

  • 00801741135064 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 60 millimeter
LX3540460V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x40x40
LUTONIX, INC.
LX3540440V
Not in Commercial Distribution

  • 00801741135057 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Length, 40 millimeter
LX3540440V

  • Peripheral angioplasty balloon catheter, drug-coated
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