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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 - 00801741176975

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X100MMX75CM
LUTONIX, INC.
LX187541004F
In Commercial Distribution

  • 00801741176975 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 100 Millimeter
LX187541004F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741176951

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X60MMX75CM
LUTONIX, INC.
LX18754604F
In Commercial Distribution

  • 00801741176951 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
LX18754604F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163449

Lutonix 035 DCB, 7mm x 100mm x 130cm, 5F
LUTONIX, INC.
LX3513071005F
In Commercial Distribution

  • 00801741163449 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
LX3513071005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163425

Lutonix 035 DCB, 6mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513062205F
In Commercial Distribution

  • 00801741163425 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 220 Millimeter
LX3513062205F

  • 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 - 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 - 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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