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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® 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

LUTONIX® Drug Coated Balloon - 00801741123849

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x150mm 5 French
LUTONIX, INC.
BSLX3513051505F
Not in Commercial Distribution

  • 00801741123849 ()

  • Catheter Length, 130 centimeter
  • Balloon Length, 150 millimeter
  • Balloon Diameter, 5 millimeter
BSLX3513051505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123832

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x120mm 5 French
LUTONIX, INC.
BSLX3513051205F
Not in Commercial Distribution

  • 00801741123832 ()

  • Balloon Length, 120 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Diameter, 5 millimeter
BSLX3513051205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123825

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x100mm 5 French
LUTONIX, INC.
BSLX3513051005F
Not in Commercial Distribution

  • 00801741123825 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Diameter, 5 millimeter
BSLX3513051005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123818

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x80mm 5 French
LUTONIX, INC.
BSLX351305805F
Not in Commercial Distribution

  • 00801741123818 ()

  • Catheter Length, 130 centimeter
  • Balloon Length, 80 millimeter
  • Balloon Diameter, 5 millimeter
BSLX351305805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123801

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x60mm 5 French
LUTONIX, INC.
BSLX351305605F
Not in Commercial Distribution

  • 00801741123801 ()

  • Catheter Length, 130 centimeter
  • Balloon Length, 60 millimeter
  • Balloon Diameter, 5 millimeter
BSLX351305605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122934

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x60mm 5 French
LUTONIX, INC.
LX35757605F
In Commercial Distribution

  • 00801741122934 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 7 millimeter
LX35757605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122927

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x40mm 5 French
LUTONIX, INC.
LX35757405F
In Commercial Distribution

  • 00801741122927 ()

  • Balloon Diameter, 7 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
LX35757405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122811

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm 5 French
LUTONIX, INC.
LX35755605F
Not in Commercial Distribution

  • 00801741122811 ()

  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
LX35755605F

  • Peripheral angioplasty balloon catheter, drug-coated
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