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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 - 00801741135521

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

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135507

Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x75
LUTONIX, INC.
LX35751020V
In Commercial Distribution

  • 00801741135507 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 10 millimeter
  • Balloon Length, 20 millimeter
LX35751020V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135484

Lutonix® AV Drug Coated Balloon PTA Catheter 9x40x75
LUTONIX, INC.
LX3575940V
In Commercial Distribution

  • 00801741135484 ()

  • Catheter Length, 75 centimeter
  • Balloon Length, 40 millimeter
  • Balloon Diameter, 9 millimeter
LX3575940V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135477

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135460

Lutonix® AV Drug Coated Balloon PTA Catheter 8x60x75
LUTONIX, INC.
LX3575860V
In Commercial Distribution

  • 00801741135460 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 8 millimeter
  • Catheter Length, 75 centimeter
LX3575860V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135231

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135217

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135194

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135170

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135156

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135149

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135125

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135095

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® 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 - 00801741126888

Lutonix 035 Drug Coated Balloon PTA Catheter .035" 130cm 6X80mm 5 French
LUTONIX, INC.
LX351306805F
In Commercial Distribution

  • 00801741126888 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 80 Millimeter
LX351306805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123900

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm 5 French
LUTONIX, INC.
BSLX3513061505F
Not in Commercial Distribution

  • 00801741123900 ()

  • Balloon Diameter, 6 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Length, 150 millimeter
BSLX3513061505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123887

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x100mm 5 French
LUTONIX, INC.
BSLX3513061005F
Not in Commercial Distribution

  • 00801741123887 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 100 millimeter
  • Catheter Length, 130 centimeter
BSLX3513061005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123863

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x60mm 5 French
LUTONIX, INC.
BSLX351306605F
Not in Commercial Distribution

  • 00801741123863 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 130 centimeter
BSLX351306605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123856

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x40mm 5 French
LUTONIX, INC.
BSLX351306405F
Not in Commercial Distribution

  • 00801741123856 ()

  • Balloon Diameter, 6 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Length, 40 millimeter
BSLX351306405F

  • Peripheral angioplasty balloon catheter, drug-coated
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