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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 5x150mm
LUTONIX, INC.
LX35755150
In Commercial Distribution

  • 00801741088193 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
LX35755150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x150mm
LUTONIX, INC.
LX35754150
In Commercial Distribution

  • 00801741088186 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
LX35754150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x120mm
LUTONIX, INC.
LX35756120
In Commercial Distribution

  • 00801741088162 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
LX35756120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x120mm
LUTONIX, INC.
LX35755120
In Commercial Distribution

  • 00801741088155 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
LX35755120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x120mm
LUTONIX, INC.
LX35754120
In Commercial Distribution

  • 00801741088148 ()

  • Catheter Length
  • Balloon Length
  • Balloon Diameter
LX35754120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 75cm 6x100mm
LUTONIX, INC.
LX35756100
Not in Commercial Distribution

  • 00801741088124 ()

  • Balloon Length,100 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Diameter,6 Millimeter
LX35756100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 75cm 5x100mm
LUTONIX, INC.
LX35755100
Not in Commercial Distribution

  • 00801741088117 ()

  • Balloon Diameter,5 Millimeter
  • Balloon Length,100 Millimeter
  • Catheter Length,75 Centimeter
LX35755100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 75cm 4x100mm
LUTONIX, INC.
LX35754100
Not in Commercial Distribution

  • 00801741088100 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,100 Millimeter
  • Catheter Length,75 Centimeter
LX35754100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm
LUTONIX, INC.
LX3575680
Not in Commercial Distribution

  • 00801741088087 ()

  • Balloon Length,80 Millimeter
  • Balloon Diameter,6 Millimeter
  • Catheter Length,75 Centimeter
LX3575680

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x80mm
LUTONIX, INC.
LX3575580
Not in Commercial Distribution

  • 00801741088070 ()

  • Catheter Length,75 Centimeter
  • Balloon Diameter,5 Millimeter
  • Balloon Length,80 Millimeter
LX3575580

  • Peripheral angioplasty balloon catheter, drug-coated
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