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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® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x40mm
LUTONIX, INC.
LX3575540
Not in Commercial Distribution

  • 00801741087998 ()

  • Balloon Diameter,5 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,40 Millimeter
LX3575540

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x40x100
LUTONIX, INC.
LX351001240V
In Commercial Distribution

  • 00801741135798 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 12 millimeter
LX351001240V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x100
LUTONIX, INC.
LX351001220V
In Commercial Distribution

  • 00801741135781 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 12 millimeter
  • Balloon Length, 20 millimeter
LX351001220V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x60x100
LUTONIX, INC.
LX351001060V
In Commercial Distribution

  • 00801741135774 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 10 millimeter
LX351001060V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x100
LUTONIX, INC.
LX351001020V
In Commercial Distribution

  • 00801741135750 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 10 millimeter
  • Balloon Length, 20 millimeter
LX351001020V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x40x100
LUTONIX, INC.
LX35100940V
In Commercial Distribution

  • 00801741135736 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 9 millimeter
LX35100940V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 7x40x100
LUTONIX, INC.
LX35100740V
Not in Commercial Distribution

  • 00801741135675 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 40 millimeter
LX35100740V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x100x100
LUTONIX, INC.
LX351006100V
Not in Commercial Distribution

  • 00801741135668 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 100 millimeter
  • Catheter Length, 100 centimeter
LX351006100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x80x100
LUTONIX, INC.
LX35100680V
Not in Commercial Distribution

  • 00801741135651 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 6 millimeter
  • Balloon Length, 80 millimeter
LX35100680V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x60x100
LUTONIX, INC.
LX35100660V
Not in Commercial Distribution

  • 00801741135644 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 6 millimeter
LX35100660V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x40x100
LUTONIX, INC.
LX35100640V
Not in Commercial Distribution

  • 00801741135637 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
LX35100640V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x100x100
LUTONIX, INC.
LX351005100V
Not in Commercial Distribution

  • 00801741135620 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length,100 millimeter
LX351005100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x80x100
LUTONIX, INC.
LX35100580V
Not in Commercial Distribution

  • 00801741135613 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 80 millimeter
LX35100580V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x40x100
LUTONIX, INC.
LX35100540V
Not in Commercial Distribution

  • 00801741135590 ()

  • Balloon Diameter, 5 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Length, 40 millimeter
LX35100540V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x80x100
LUTONIX, INC.
LX35100480V
Not in Commercial Distribution

  • 00801741135576 ()

  • Balloon Length, 80 millimeter
  • Balloon Diameter, 4 millimeter
  • Catheter Length, 100 centimeter
LX35100480V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x40x100
LUTONIX, INC.
LX35100440V
Not in Commercial Distribution

  • 00801741135552 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
LX35100440V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x75
LUTONIX, INC.
LX35751220V
In Commercial Distribution

  • 00801741135538 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 12 millimeter
  • Balloon Length, 20 millimeter
LX35751220V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x60x75
LUTONIX, INC.
LX35751060V
In Commercial Distribution

  • 00801741135521 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 10 millimeter
  • Balloon Length, 60 millimeter
LX35751060V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x40x75
LUTONIX, INC.
LX35751040V
In Commercial Distribution

  • 00801741135514 ()

  • Balloon Diameter, 10 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
LX35751040V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x75
LUTONIX, INC.
LX35751020V
In Commercial Distribution

  • 00801741135507 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 10 millimeter
  • Balloon Length, 20 millimeter
LX35751020V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x40x75
LUTONIX, INC.
LX3575940V
In Commercial Distribution

  • 00801741135484 ()

  • Catheter Length, 75 centimeter
  • Balloon Length, 40 millimeter
  • Balloon Diameter, 9 millimeter
LX3575940V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x60x75
LUTONIX, INC.
LX3575860V
In Commercial Distribution

  • 00801741135460 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 8 millimeter
  • Catheter Length, 75 centimeter
LX3575860V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x40x75
LUTONIX, INC.
LX3575840V
In Commercial Distribution

  • 00801741135453 ()

  • Balloon Diameter, 8 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 40 millimeter
LX3575840V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 7x60x75
LUTONIX, INC.
LX3575760V
In Commercial Distribution

  • 00801741135439 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 60millimeter
LX3575760V

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm
LUTONIX, INC.
BSCLX35130760
Not in Commercial Distribution

  • 00801741109454 ()

  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
BSCLX35130760

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm
LUTONIX, INC.
BSCLX35130740
Not in Commercial Distribution

  • 00801741109447 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
BSCLX35130740

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x60mm
LUTONIX, INC.
BSCLX3575760
Not in Commercial Distribution

  • 00801741109430 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
BSCLX3575760

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x40mm
LUTONIX, INC.
BSCLX3575740
Not in Commercial Distribution

  • 00801741109423 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 75 Centimeter
BSCLX3575740

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x150mm
LUTONIX, INC.
BSCLX35756150
In Commercial Distribution

  • 00801741105081 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
BSCLX35756150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x150mm
LUTONIX, INC.
BSCLX35755150
In Commercial Distribution

  • 00801741105074 ()

  • Balloon Diameter
  • Balloon Length
  • Catheter Length
BSCLX35755150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x150mm
LUTONIX, INC.
BSCLX35754150
In Commercial Distribution

  • 00801741105067 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
BSCLX35754150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x120mm
LUTONIX, INC.
BSCLX35756120
In Commercial Distribution

  • 00801741105050 ()

  • Balloon Length
  • Catheter Length
BSCLX35756120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x120mm
LUTONIX, INC.
BSCLX35755120
In Commercial Distribution

  • 00801741105043 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
BSCLX35755120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x120mm
LUTONIX, INC.
BSCLX35754120
In Commercial Distribution

  • 00801741105036 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX35754120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm
LUTONIX, INC.
BSCLX351306150
Not in Commercial Distribution

  • 00801741105029 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX351306150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x150mm
LUTONIX, INC.
BSCLX351305150
Not in Commercial Distribution

  • 00801741105012 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
BSCLX351305150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm
LUTONIX, INC.
BSCLX351306120
Not in Commercial Distribution

  • 00801741104992 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX351306120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x120mm
LUTONIX, INC.
BSCLX351304120
Not in Commercial Distribution

  • 00801741104978 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
BSCLX351304120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm
LUTONIX, INC.
BSCLX3575660
In Commercial Distribution

  • 00801741098567 ()

  • Balloon Length, 60mm
  • Balloon Diameter, 6mm
  • Catheter Length, 75cm
BSCLX3575660

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x100mm
LUTONIX, INC.
BSCLX35756100
In Commercial Distribution

  • 00801741098550 ()

  • Balloon Length, 100mm
  • Catheter Length,75cm
  • Balloon Diameter, 6mm
BSCLX35756100

  • Peripheral angioplasty balloon catheter, drug-coated
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