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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 - 00801741199424

Lutonix 018 7X80MMX150CM
LUTONIX, INC.
LX181507805F
In Commercial Distribution

  • 00801741199424 ()

  • Balloon Length, 80 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
LX181507805F

  • 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 - 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

LUTONIX® Drug Coated Balloon - 00801741184697

Lutonix 018 6X300MMX100CM
LUTONIX, INC.
LX1810063005F
In Commercial Distribution

  • 00801741184697 ()

  • Balloon Length, 300 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
LX1810063005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184673

Lutonix 018 4X300MMX100CM
LUTONIX, INC.
LX1810043005F
In Commercial Distribution

  • 00801741184673 ()

  • Balloon Length, 300 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 4 Millimeter
LX1810043005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177743

Lutonix 018 7X100MMX130CM
LUTONIX, INC.
LX1813071005F
In Commercial Distribution

  • 00801741177743 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 7 Millimeter
LX1813071005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177729

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X60MMX130CM
LUTONIX, INC.
LX181307605F
In Commercial Distribution

  • 00801741177729 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
LX181307605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163470

Lutonix 035 DCB, 7mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513072205F
In Commercial Distribution

  • 00801741163470 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX3513072205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163463

Lutonix 035 DCB, 7mm x 150mm x 130cm, 5F
LUTONIX, INC.
LX3513071505F
In Commercial Distribution

  • 00801741163463 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
LX3513071505F

  • Peripheral angioplasty balloon catheter, drug-coated
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