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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 - 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

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
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