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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, 130cm, 7x120mm
LUTONIX, INC.
LX351307120
In Commercial Distribution

  • 00801741088735 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 120 Millimeter
LX351307120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm
LUTONIX, INC.
LX351306120
Not in Commercial Distribution

  • 00801741088728 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
LX351306120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x120mm
LUTONIX, INC.
LX351305120
Not in Commercial Distribution

  • 00801741088711 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
LX351305120

  • 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 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 .035 130cm 5x80mm
LUTONIX, INC.
LX35130580
Not in Commercial Distribution

  • 00801741088636 ()

  • Balloon Diameter,5 Millimeter
  • Balloon Length,80 Millimeter
  • Catheter Length,130 Centimeter
LX35130580

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x80mm
LUTONIX, INC.
LX35130480
Not in Commercial Distribution

  • 00801741088629 ()

  • Balloon Length,80 Millimeter
  • Balloon Diameter,4 Millimeter
  • Catheter Length,130 Centimeter
LX35130480

  • 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
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x40mm
LUTONIX, INC.
LX35130640
Not in Commercial Distribution

  • 00801741088568 ()

  • Catheter Length,130 Centimeter
  • Balloon Length,40 Millimeter
  • Balloon Diameter,6 Millimeter
LX35130640

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 5x40mm
LUTONIX, INC.
LX35130540
Not in Commercial Distribution

  • 00801741088551 ()

  • Catheter Length,130 Centimeter
  • Balloon Length,40 Millimeter
  • Balloon Diameter,5 Millimeter
LX35130540

  • Peripheral angioplasty balloon catheter, drug-coated
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