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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 - 00801741123382

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x150mm 5 French
LUTONIX, INC.
BSLX357541505F
In Commercial Distribution

  • 00801741123382 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 150 millimeter
  • Catheter Length, 75 centimeter
BSLX357541505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123375

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x120mm 5 French
LUTONIX, INC.
BSLX357541205F
In Commercial Distribution

  • 00801741123375 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 120 millimeter
BSLX357541205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123368

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x100mm 5 French
LUTONIX, INC.
BSLX357541005F
Not in Commercial Distribution

  • 00801741123368 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 100 millimeter
BSLX357541005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123351

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x80mm 5 French
LUTONIX, INC.
BSLX35754805F
Not in Commercial Distribution

  • 00801741123351 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 80 millimeter
  • Catheter Length, 75 centimeter
BSLX35754805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123344

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm 5 French
LUTONIX, INC.
BSLX35754605F
Not in Commercial Distribution

  • 00801741123344 ()

  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
BSLX35754605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123337

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm 5 French
LUTONIX, INC.
BSLX35754405F
Not in Commercial Distribution

  • 00801741123337 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
BSLX35754405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123320

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm 5 French
LUTONIX, INC.
LX351307605F
In Commercial Distribution

  • 00801741123320 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 7 Millimeter
LX351307605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123313

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm 5 French
LUTONIX, INC.
LX351307405F
In Commercial Distribution

  • 00801741123313 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
LX351307405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123306

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm 5 French
LUTONIX, INC.
LX3513061505F
In Commercial Distribution

  • 00801741123306 ()

  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX3513061505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123290

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm 5 French
LUTONIX, INC.
LX3513061205F
In Commercial Distribution

  • 00801741123290 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 6 Millimeter
LX3513061205F

  • Peripheral angioplasty balloon catheter, drug-coated
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