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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® 018 Drug Coated Balloon PTA Catheter 5X120MMX100CM
LUTONIX, INC.
LX1810051205F
In Commercial Distribution

  • 00801741177330 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
LX1810051205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X100MMX100CM
LUTONIX, INC.
LX1810051005F
In Commercial Distribution

  • 00801741177323 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 5 Millimeter
LX1810051005F

  • Peripheral angioplasty balloon catheter, drug-coated
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
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
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
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
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
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
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
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
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