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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 5x80x100
LUTONIX, INC.
LX35100580V
Not in Commercial Distribution

  • 00801741135613 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 80 millimeter
LX35100580V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x60x100
LUTONIX, INC.
LX35100560V
Not in Commercial Distribution

  • 00801741135606 ()

  • Balloon Diameter, 5 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
LX35100560V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x40x100
LUTONIX, INC.
LX35100540V
Not in Commercial Distribution

  • 00801741135590 ()

  • Balloon Diameter, 5 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Length, 40 millimeter
LX35100540V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x100x100
LUTONIX, INC.
LX351004100V
Not in Commercial Distribution

  • 00801741135583 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 4 millimeter
LX351004100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x80x100
LUTONIX, INC.
LX35100480V
Not in Commercial Distribution

  • 00801741135576 ()

  • Balloon Length, 80 millimeter
  • Balloon Diameter, 4 millimeter
  • Catheter Length, 100 centimeter
LX35100480V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x60x100
LUTONIX, INC.
LX35100460V
Not in Commercial Distribution

  • 00801741135569 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 60 millimeter
LX35100460V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x40x100
LUTONIX, INC.
LX35100440V
Not in Commercial Distribution

  • 00801741135552 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
LX35100440V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x40x75
LUTONIX, INC.
LX35751240V
In Commercial Distribution

  • 00801741135545 ()

  • Balloon Diameter, 12 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
LX35751240V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x75
LUTONIX, INC.
LX35751220V
In Commercial Distribution

  • 00801741135538 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 12 millimeter
  • Balloon Length, 20 millimeter
LX35751220V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x60x75
LUTONIX, INC.
LX35751060V
In Commercial Distribution

  • 00801741135521 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 10 millimeter
  • Balloon Length, 60 millimeter
LX35751060V

  • Peripheral angioplasty balloon catheter, drug-coated
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