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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 - 00801741123870

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x80mm 5 French
LUTONIX, INC.
BSLX351306805F
Not in Commercial Distribution

  • 00801741123870 ()

  • Balloon Length, 80 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Diameter, 6 millimeter
BSLX351306805F

  • 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

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 - 00801741123795

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x40mm 5 French
LUTONIX, INC.
BSLX351305405F
Not in Commercial Distribution

  • 00801741123795 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Diameter, 5 millimeter
BSLX351305405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123788

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x150mm 5 French
LUTONIX, INC.
BSLX3513041505F
Not in Commercial Distribution

  • 00801741123788 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Length, 150 millimeter
BSLX3513041505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123771

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x120mm 5 French
LUTONIX, INC.
BSLX3513041205F
Not in Commercial Distribution

  • 00801741123771 ()

  • Catheter Length, 130 centimeter
  • Balloon Length, 120 millimeter
  • Balloon Diameter, 4 millimeter
BSLX3513041205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123764

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x100mm 5 French
LUTONIX, INC.
BSLX3513041005F
Not in Commercial Distribution

  • 00801741123764 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Length, 100 millimeter
BSLX3513041005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123757

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x80mm 5 French
LUTONIX, INC.
BSLX351304805F
Not in Commercial Distribution

  • 00801741123757 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Length, 80 millimeter
BSLX351304805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123740

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x60mm 5 French
LUTONIX, INC.
BSLX351304605F
Not in Commercial Distribution

  • 00801741123740 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Diameter, 4 millimeter
BSLX351304605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123733

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x40mm 5 French
LUTONIX, INC.
BSLX351304405F
Not in Commercial Distribution

  • 00801741123733 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Diameter, 4 millimeter
BSLX351304405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123528

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x60mm 5 French
LUTONIX, INC.
BSLX35757605F
Not in Commercial Distribution

  • 00801741123528 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 75 centimeter
BSLX35757605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123511

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x40mm 5 French
LUTONIX, INC.
BSLX35757405F
Not in Commercial Distribution

  • 00801741123511 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 40 millimeter
BSLX35757405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123504

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x150mm 5 French
LUTONIX, INC.
BSLX357561505F
In Commercial Distribution

  • 00801741123504 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 150 millimeter
  • Catheter Length, 75 centimeter
BSLX357561505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123498

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x120mm 5 French
LUTONIX, INC.
BSLX357561205F
In Commercial Distribution

  • 00801741123498 ()

  • Catheter Length, 75 centimeter
  • Balloon Length, 120 millimeter
  • Balloon Diameter, 6 millimeter
BSLX357561205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123481

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x100mm 5 French
LUTONIX, INC.
BSLX357561005F
Not in Commercial Distribution

  • 00801741123481 ()

  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 100 millimeter
BSLX357561005F

  • Peripheral angioplasty balloon catheter, drug-coated
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