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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 - 00801741123412

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x80mm 5 French
LUTONIX, INC.
BSLX35755805F
Not in Commercial Distribution

  • 00801741123412 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 80 millimeter
BSLX35755805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123405

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm 5 French
LUTONIX, INC.
BSLX35755605F
Not in Commercial Distribution

  • 00801741123405 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length, 75 centimeter
BSLX35755605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123399

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x40mm 5 French
LUTONIX, INC.
BSLX35755405F
Not in Commercial Distribution

  • 00801741123399 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 40 millimeter
BSLX35755405F

  • Peripheral angioplasty balloon catheter, drug-coated

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
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