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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 - 00801741199257

Lutonix 018 4X220MMX150CM
LUTONIX, INC.
LX1815042204F
In Commercial Distribution

  • 00801741199257 ()

  • Balloon Length, 220 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 4 millimeter
LX1815042204F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199240

Lutonix 018 4X150MMX150CM
LUTONIX, INC.
LX1815041504F
In Commercial Distribution

  • 00801741199240 ()

  • Balloon Length, 150 millimeter
  • Balloon Diameter, 4 millimeter
  • Catheter Length, 150 centimeter
LX1815041504F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199233

Lutonix 018 4X120MMX150CM
LUTONIX, INC.
LX1815041204F
In Commercial Distribution

  • 00801741199233 ()

  • Balloon Length, 120 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 4 millimeter
LX1815041204F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199226

Lutonix 018 4X100MMX150CM
LUTONIX, INC.
LX1815041004F
In Commercial Distribution

  • 00801741199226 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 100 millimeter
  • Catheter Length, 150 centimeter
LX1815041004F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199219

Lutonix 018 4X80MMX150CM
LUTONIX, INC.
LX181504804F
In Commercial Distribution

  • 00801741199219 ()

  • Catheter Length, 150 centimeter
  • Balloon Length, 80 millimeter
  • Balloon Diameter, 4 millimeter
LX181504804F

  • Peripheral angioplasty balloon catheter, drug-coated

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

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

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 - 00801741184680

Lutonix 018 5X300MMX100CM
LUTONIX, INC.
LX1810053005F
In Commercial Distribution

  • 00801741184680 ()

  • Balloon Length, 300 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 100 Centimeter
LX1810053005F

  • 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 - 00801741178740

LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x220mm
LUTONIX, INC.
LX351307220
Not in Commercial Distribution

  • 00801741178740 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX351307220

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741178733

LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 6x220mm
LUTONIX, INC.
LX351306220
Not in Commercial Distribution

  • 00801741178733 ()

  • Balloon Length, 220 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
LX351306220

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177774

Lutonix 018 7X220MMX130CM
LUTONIX, INC.
LX1813072205F
In Commercial Distribution

  • 00801741177774 ()

  • Balloon Diameter, 7 Milimeter
  • Balloon Length, 220 Millimeter
  • Catheter Length, 130 Centimeter
LX1813072205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177767

Lutonix 018 7X150MMX130CM
LUTONIX, INC.
LX1813071505F
In Commercial Distribution

  • 00801741177767 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX1813071505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177750

Lutonix 018 7X120MMX130CM
LUTONIX, INC.
LX1813071205F
In Commercial Distribution

  • 00801741177750 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
LX1813071205F

  • 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 - 00801741177736

Lutonix 018 7X80MMX130CM
LUTONIX, INC.
LX181307805F
In Commercial Distribution

  • 00801741177736 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX181307805F

  • 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 - 00801741177712

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X40MMX130CM
LUTONIX, INC.
LX181307405F
In Commercial Distribution

  • 00801741177712 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX181307405F

  • Peripheral angioplasty balloon catheter, drug-coated
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