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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® Drug Coated Balloon - 00801741187766

Lutonix 035 7X100MMX100CM
LUTONIX, INC.
LX351007100V
In Commercial Distribution

  • 00801741187766 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Length, 100 Millimeter
LX351007100V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741187759

Lutonix 035 7X80MMX100CM
LUTONIX, INC.
LX35100780V
In Commercial Distribution

  • 00801741187759 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 80 Millimeter
  • Catheter Length, 100 Centimeter
LX35100780V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741187704

Lutonix 035 7X100MMX75CM
LUTONIX, INC.
LX35757100V
In Commercial Distribution

  • 00801741187704 ()

  • Balloon Length, 100 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
LX35757100V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741187698

Lutonix 035 7X80MMX75CM
LUTONIX, INC.
LX3575780V
In Commercial Distribution

  • 00801741187698 ()

  • Balloon Length, 80 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
LX3575780V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741187681

Lutonix 035 12X60MMX40CM
LUTONIX, INC.
LX35401260V
In Commercial Distribution

  • 00801741187681 ()

  • Catheter Length, 40 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 12 Millimeter
LX35401260V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741187643

Lutonix 035 7X100MMX40CM
LUTONIX, INC.
LX35407100V
In Commercial Distribution

  • 00801741187643 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 40 Centimeter
  • Balloon Length, 100 Millimeter
LX35407100V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741187636

Lutonix 035 7X80MMX40CM
LUTONIX, INC.
LX3540780V
In Commercial Distribution

  • 00801741187636 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 80 Millimeter
  • Catheter Length, 40 Centimeter
LX3540780V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184727

Lutonix 018 6X300MMX130CM
LUTONIX, INC.
LX1813063005F
In Commercial Distribution

  • 00801741184727 ()

  • Balloon Length, 300 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
LX1813063005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184710

Lutonix 018 5X300MMX130CM
LUTONIX, INC.
LX1813053005F
In Commercial Distribution

  • 00801741184710 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 300 Millimeter
  • Balloon Diameter, 5 Millimeter
LX1813053005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184703

Lutonix 018 4X300MMX130CM
LUTONIX, INC.
LX1813043005F
In Commercial Distribution

  • 00801741184703 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 300 Millimeter
  • Balloon Diameter, 4 Millimeter
LX1813043005F

  • Peripheral angioplasty balloon catheter, drug-coated
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