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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 100cm 6x100mm
LUTONIX, INC.
LX351006100
In Commercial Distribution

  • 00801741088407 ()

  • Balloon Length,100 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Diameter,6 Millimeter
LX351006100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 5x100mm
LUTONIX, INC.
LX351005100
In Commercial Distribution

  • 00801741088391 ()

  • Balloon Diameter,5 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Length,100 Millimeter
LX351005100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 4x100mm
LUTONIX, INC.
LX351004100
In Commercial Distribution

  • 00801741088384 ()

  • Catheter Length,100 Centimeter
  • Balloon Diameter,4 Millimeter
  • Balloon Length,100 Millimeter
LX351004100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x80mm
LUTONIX, INC.
LX35100680
In Commercial Distribution

  • 00801741088360 ()

  • Balloon Diameter,6 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Length,80 Millimeter
LX35100680

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 5x80mm
LUTONIX, INC.
LX35100580
In Commercial Distribution

  • 00801741088353 ()

  • Balloon Length,80 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Diameter,5 Millimeter
LX35100580

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 4x80mm
LUTONIX, INC.
LX35100480
In Commercial Distribution

  • 00801741088346 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,80 Millimeter
  • Catheter Length,100 Centimeter
LX35100480

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 7x60mm
LUTONIX, INC.
LX35100760
In Commercial Distribution

  • 00801741088339 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 7 Millimeter
LX35100760

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x60mm
LUTONIX, INC.
LX35100660
In Commercial Distribution

  • 00801741088322 ()

  • Balloon Diameter,6 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,100 Centimeter
LX35100660

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 5x60mm
LUTONIX, INC.
LX35100560
In Commercial Distribution

  • 00801741088315 ()

  • Balloon Length,60 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Diameter,5 Millimeter
LX35100560

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 4x60mm
LUTONIX, INC.
LX35100460
In Commercial Distribution

  • 00801741088308 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,100 Centimeter
LX35100460

  • Peripheral angioplasty balloon catheter, drug-coated
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