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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 - 00801741135750

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135743

Lutonix® AV Drug Coated Balloon PTA Catheter 9x60x100
LUTONIX, INC.
LX35100960V
In Commercial Distribution

  • 00801741135743 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 9 millimeter
  • Balloon Length, 60 millimeter
LX35100960V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135736

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135729

Lutonix® AV Drug Coated Balloon PTA Catheter 9x20x100
LUTONIX, INC.
LX35100920V
In Commercial Distribution

  • 00801741135729 ()

  • Balloon Length, 20 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 9 millimeter
LX35100920V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135712

Lutonix® AV Drug Coated Balloon PTA Catheter 8x60x100
LUTONIX, INC.
LX35100860V
In Commercial Distribution

  • 00801741135712 ()

  • Balloon Diameter, 8 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
LX35100860V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135705

Lutonix® AV Drug Coated Balloon PTA Catheter 8x40x100
LUTONIX, INC.
LX35100840V
In Commercial Distribution

  • 00801741135705 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 8 millimeter
LX35100840V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135699

Lutonix® AV Drug Coated Balloon PTA Catheter 8x20x100
LUTONIX, INC.
LX35100820V
In Commercial Distribution

  • 00801741135699 ()

  • Catheter Length, 100 centimeter
  • Balloon Length, 20 millimeter
  • Balloon Diameter, 8 millimeter
LX35100820V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135682

Lutonix® AV Drug Coated Balloon PTA Catheter 7x60x100
LUTONIX, INC.
LX35100760V
Not in Commercial Distribution

  • 00801741135682 ()

  • Catheter Length, 100 centimeter
  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
LX35100760V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135675

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135668

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135651

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135644

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135613

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135606

Lutonix® AV Drug Coated Balloon PTA Catheter 5x60x100
LUTONIX, INC.
LX35100560V
Not in Commercial Distribution

  • 00801741135606 ()

  • Balloon Diameter, 5 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
LX35100560V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135590

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135583

Lutonix® AV Drug Coated Balloon PTA Catheter 4x100x100
LUTONIX, INC.
LX351004100V
Not in Commercial Distribution

  • 00801741135583 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 4 millimeter
LX351004100V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135569

Lutonix® AV Drug Coated Balloon PTA Catheter 4x60x100
LUTONIX, INC.
LX35100460V
Not in Commercial Distribution

  • 00801741135569 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 60 millimeter
LX35100460V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® 035 Drug Coated Balloon PTA Catheter - 00801741135545

Lutonix® AV Drug Coated Balloon PTA Catheter 12x40x75
LUTONIX, INC.
LX35751240V
In Commercial Distribution

  • 00801741135545 ()

  • Balloon Diameter, 12 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
LX35751240V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135521

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135507

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
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