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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 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
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