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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 - 00801741135187

Lutonix® AV Drug Coated Balloon PTA Catheter 7x60x40
LUTONIX, INC.
LX3540760V
In Commercial Distribution

  • 00801741135187 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 40 centimeter
LX3540760V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135163

Lutonix® AV Drug Coated Balloon PTA Catheter 6x100x40
LUTONIX, INC.
LX35406100V
Not in Commercial Distribution

  • 00801741135163 ()

  • Balloon Length, 100 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 40 centimeter
LX35406100V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135132

Lutonix® AV Drug Coated Balloon PTA Catheter 6x40x40
LUTONIX, INC.
LX3540640V
Not in Commercial Distribution

  • 00801741135132 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 6 millimeter
  • Balloon Length, 40 millimeter
LX3540640V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135118

Lutonix® AV Drug Coated Balloon PTA Catheter 5x80x40
LUTONIX, INC.
LX3540580V
Not in Commercial Distribution

  • 00801741135118 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 80 millimeter
LX3540580V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135101

Lutonix® AV Drug Coated Balloon PTA Catheter 5x60x40
LUTONIX, INC.
LX3540560V
Not in Commercial Distribution

  • 00801741135101 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length, 40 centimeter
LX3540560V

  • Peripheral angioplasty balloon catheter, drug-coated

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® Drug Coated Balloon - 00801741123924

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm 5 French
LUTONIX, INC.
BSLX351307605F
Not in Commercial Distribution

  • 00801741123924 ()

  • Balloon Diameter, 7 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 130 centimeter
BSLX351307605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123917

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm 5 French
LUTONIX, INC.
BSLX351307405F
Not in Commercial Distribution

  • 00801741123917 ()

  • Balloon Diameter, 7 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Length, 40 millimeter
BSLX351307405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123894

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm 5 French
LUTONIX, INC.
BSLX3513061205F
Not in Commercial Distribution

  • 00801741123894 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 120 millimeter
  • Catheter Length, 130 centimeter
BSLX3513061205F

  • Peripheral angioplasty balloon catheter, drug-coated
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