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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 - 00801741199202

Lutonix 018 4X60MMX150CM
LUTONIX, INC.
LX181504604F
In Commercial Distribution

  • 00801741199202 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Length, 60 millimeter
LX181504604F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199196

Lutonix 018 4X40MMX150CM
LUTONIX, INC.
LX181504404F
In Commercial Distribution

  • 00801741199196 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 40 millimeter
LX181504404F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741187803

Lutonix 035 12X60MMX100CM
LUTONIX, INC.
LX351001260V
In Commercial Distribution

  • 00801741187803 ()

  • Balloon Diameter, 12 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Length, 60 Millimeter
LX351001260V

  • Peripheral angioplasty balloon catheter, drug-coated

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
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