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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 - 00801741135378

Lutonix® AV Drug Coated Balloon PTA Catheter 5x100x75
LUTONIX, INC.
LX35755100V
In Commercial Distribution

  • 00801741135378 ()

  • Balloon Length, 100 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length,75 centimeter
LX35755100V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135361

Lutonix® AV Drug Coated Balloon PTA Catheter 5x80x75
LUTONIX, INC.
LX3575580V
In Commercial Distribution

  • 00801741135361 ()

  • Balloon Diameter,5 millimeter
  • Balloon Length, 80 millimeter
  • Catheter Length, 75 centimeter
LX3575580V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135347

Lutonix® AV Drug Coated Balloon PTA Catheter 5x40x75
LUTONIX, INC.
LX3575540V
In Commercial Distribution

  • 00801741135347 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
LX3575540V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135323

Lutonix® AV Drug Coated Balloon PTA Catheter 4x80x75
LUTONIX, INC.
LX3575480V
In Commercial Distribution

  • 00801741135323 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 80 millimeter
LX3575480V

  • 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 - 00801741135248

Lutonix® AV Drug Coated Balloon PTA Catheter 9x60x40
LUTONIX, INC.
LX3540960V
Not in Commercial Distribution

  • 00801741135248 ()

  • Catheter Length, 40 centimeter
  • Balloon Length, 60 millimeter
  • Balloon Diameter, 9 millimeter
LX3540960V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135231

Lutonix® AV Drug Coated Balloon PTA Catheter 9x40x40
LUTONIX, INC.
LX3540940V
Not in Commercial Distribution

  • 00801741135231 ()

  • Balloon Diameter, 9 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 40 centimeter
LX3540940V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135217

Lutonix® AV Drug Coated Balloon PTA Catheter 8x60x40
LUTONIX, INC.
LX3540860V
In Commercial Distribution

  • 00801741135217 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 8 millimeter
  • Balloon Length, 60 millimeter
LX3540860V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135194

Lutonix® AV Drug Coated Balloon PTA Catheter 8x20x40
LUTONIX, INC.
LX3540820V
In Commercial Distribution

  • 00801741135194 ()

  • Balloon Length, 20 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Diameter, 8 millimeter
LX3540820V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135163

Lutonix® AV Drug Coated Balloon PTA Catheter 6x100x40
LUTONIX, INC.
LX35406100V
Not in Commercial Distribution

  • 00801741135163 ()

  • Balloon Length, 100 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 40 centimeter
LX35406100V

  • Peripheral angioplasty balloon catheter, drug-coated
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