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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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Innova™ Vascular - 08714729873532

Self-Expanding Stent System
BOSTON SCIENTIFIC CORPORATION
H74939293050270
In Commercial Distribution

  • 08714729873532 ()

  • 20 mm Stent Length
  • 75 cm Effective Length
  • 5 mm Stent Diameter
H74939293050270

  • Peripheral artery stent, bare-metal

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 - 00801741135538

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135781

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 ® 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 - 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 - 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

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135477

Lutonix® AV Drug Coated Balloon PTA Catheter 9x20x75
LUTONIX, INC.
LX3575920V
In Commercial Distribution

  • 00801741135477 ()

  • Balloon Diameter, 9 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 20 millimeter
LX3575920V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135286

Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x40
LUTONIX, INC.
LX35401220V
In Commercial Distribution

  • 00801741135286 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 12 millimeter
  • Catheter Length, 40 centimeter
LX35401220V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135255

Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x40
LUTONIX, INC.
LX35401020V
In Commercial Distribution

  • 00801741135255 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 10 millimeter
  • Catheter Length, 40 centimeter
LX35401020V

  • Peripheral angioplasty balloon catheter, drug-coated
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