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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® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x80mm 5 French
LUTONIX, INC.
LX35754805F
Not in Commercial Distribution

  • 00801741122750 ()

  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 80 Millimeter
  • Catheter Length, 75 Centimeter
LX35754805F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm 5 French
LUTONIX, INC.
LX35754605F
Not in Commercial Distribution

  • 00801741122743 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 60 Millimeter
LX35754605F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm 5 French
LUTONIX, INC.
LX35754405F
Not in Commercial Distribution

  • 00801741122736 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
LX35754405F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x120mm
LUTONIX, INC.
LX351304120
Not in Commercial Distribution

  • 00801741088704 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
LX351304120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm 7x100mm
LUTONIX, INC.
LX351307100
Not in Commercial Distribution

  • 00801741088698 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
LX351307100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x100mm
LUTONIX, INC.
LX351306100
Not in Commercial Distribution

  • 00801741088681 ()

  • Balloon Length,100 Millimeter
  • Catheter Length,130 Centimeter
  • Balloon Diameter,6 Millimeter
LX351306100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 5x100mm
LUTONIX, INC.
LX351305100
Not in Commercial Distribution

  • 00801741088674 ()

  • Balloon Diameter,5 Millimeter
  • Catheter Length,130 Centimeter
  • Balloon Length,100 Millimeter
LX351305100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x100mm
LUTONIX, INC.
LX351304100
Not in Commercial Distribution

  • 00801741088667 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,100 Millimeter
  • Catheter Length,130 Centimeter
LX351304100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x80mm
LUTONIX, INC.
LX35130780
In Commercial Distribution

  • 00801741088650 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX35130780

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x60mm
LUTONIX, INC.
LX35130460
Not in Commercial Distribution

  • 00801741088582 ()

  • Balloon Diameter,4 Millimeter
  • Catheter Length,130 Centimeter
  • Balloon Length,60 Millimeter
LX35130460

  • Peripheral angioplasty balloon catheter, drug-coated
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