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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 - 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

LUTONIX® Drug Coated Balloon - 00801741123474

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm 5 French
LUTONIX, INC.
BSLX35756805F
Not in Commercial Distribution

  • 00801741123474 ()

  • Balloon Length, 80 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 6 millimeter
BSLX35756805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123467

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm 5 French
LUTONIX, INC.
BSLX35756605F
Not in Commercial Distribution

  • 00801741123467 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 6 millimeter
BSLX35756605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123450

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x40mm 5 French
LUTONIX, INC.
BSLX35756405F
Not in Commercial Distribution

  • 00801741123450 ()

  • Catheter Length, 75 centimeter
  • Balloon Length, 40 millimeter
  • Balloon Diameter, 6 millimeter
BSLX35756405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123443

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x150mm 5 French
LUTONIX, INC.
BSLX357551505F
In Commercial Distribution

  • 00801741123443 ()

  • Balloon Diameter, 5 millimeter
  • Balloon Length, 150 millimeter
  • Catheter Length, 75 centimeter
BSLX357551505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123436

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x120mm 5 French
LUTONIX, INC.
BSLX357551205F
In Commercial Distribution

  • 00801741123436 ()

  • Balloon Diameter, 5 millimeter
  • Balloon Length, 120 millimeter
  • Catheter Length, 75 centimeter
BSLX357551205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123429

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x100mm 5 French
LUTONIX, INC.
BSLX357551005F
Not in Commercial Distribution

  • 00801741123429 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
BSLX357551005F

  • Peripheral angioplasty balloon catheter, drug-coated
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