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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 - 00801741135088

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135071

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® 035 Drug Coated Balloon PTA Catheter - 00801741135064

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135057

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

LUTONIX® Drug Coated Balloon - 00801741199462

Lutonix 018 7X220MMX150CM
LUTONIX, INC.
LX1815072205F
In Commercial Distribution

  • 00801741199462 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 220 millimeter
LX1815072205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199455

Lutonix 018 7X150MMX150CM
LUTONIX, INC.
LX1815071505F
In Commercial Distribution

  • 00801741199455 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 150 millimeter
LX1815071505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199448

Lutonix 018 7X120MMX150CM
LUTONIX, INC.
LX1815071205F
In Commercial Distribution

  • 00801741199448 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 120 millimeter
LX1815071205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199431

Lutonix 018 7X100MMX150CM
LUTONIX, INC.
LX1815071005F
In Commercial Distribution

  • 00801741199431 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
LX1815071005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199424

Lutonix 018 7X80MMX150CM
LUTONIX, INC.
LX181507805F
In Commercial Distribution

  • 00801741199424 ()

  • Balloon Length, 80 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
LX181507805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199417

Lutonix 018 7X60MMX150CM
LUTONIX, INC.
LX181507605F
In Commercial Distribution

  • 00801741199417 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 150 centimeter
LX181507605F

  • Peripheral angioplasty balloon catheter, drug-coated
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