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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 - 00801741122736

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm 5 French
LUTONIX, INC.
LX35754405F
Not in Commercial Distribution

  • 00801741122736 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
LX35754405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741109454

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm
LUTONIX, INC.
BSCLX35130760
Not in Commercial Distribution

  • 00801741109454 ()

  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
BSCLX35130760

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741109447

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm
LUTONIX, INC.
BSCLX35130740
Not in Commercial Distribution

  • 00801741109447 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
BSCLX35130740

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741109430

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x60mm
LUTONIX, INC.
BSCLX3575760
Not in Commercial Distribution

  • 00801741109430 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
BSCLX3575760

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741109423

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x40mm
LUTONIX, INC.
BSCLX3575740
Not in Commercial Distribution

  • 00801741109423 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 75 Centimeter
BSCLX3575740

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741126888

Lutonix 035 Drug Coated Balloon PTA Catheter .035" 130cm 6X80mm 5 French
LUTONIX, INC.
LX351306805F
In Commercial Distribution

  • 00801741126888 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 80 Millimeter
LX351306805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123924

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm 5 French
LUTONIX, INC.
BSLX351307605F
Not in Commercial Distribution

  • 00801741123924 ()

  • Balloon Diameter, 7 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 130 centimeter
BSLX351307605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123917

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm 5 French
LUTONIX, INC.
BSLX351307405F
Not in Commercial Distribution

  • 00801741123917 ()

  • Balloon Diameter, 7 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Length, 40 millimeter
BSLX351307405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123900

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm 5 French
LUTONIX, INC.
BSLX3513061505F
Not in Commercial Distribution

  • 00801741123900 ()

  • Balloon Diameter, 6 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Length, 150 millimeter
BSLX3513061505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123894

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm 5 French
LUTONIX, INC.
BSLX3513061205F
Not in Commercial Distribution

  • 00801741123894 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 120 millimeter
  • Catheter Length, 130 centimeter
BSLX3513061205F

  • Peripheral angioplasty balloon catheter, drug-coated
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