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 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 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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