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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 - 00801741105043

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x120mm
LUTONIX, INC.
BSCLX35755120
In Commercial Distribution

  • 00801741105043 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
BSCLX35755120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741105036

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x120mm
LUTONIX, INC.
BSCLX35754120
In Commercial Distribution

  • 00801741105036 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX35754120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741105029

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm
LUTONIX, INC.
BSCLX351306150
Not in Commercial Distribution

  • 00801741105029 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX351306150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741105005

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x150mm
LUTONIX, INC.
BSCLX351304150
Not in Commercial Distribution

  • 00801741105005 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
BSCLX351304150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741104992

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm
LUTONIX, INC.
BSCLX351306120
Not in Commercial Distribution

  • 00801741104992 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX351306120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741104985

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x120mm
LUTONIX, INC.
BSCLX351305120
Not in Commercial Distribution

  • 00801741104985 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX351305120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741104978

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x120mm
LUTONIX, INC.
BSCLX351304120
Not in Commercial Distribution

  • 00801741104978 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
BSCLX351304120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177156

LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X40MMX75CM
LUTONIX, INC.
LX18757405F
In Commercial Distribution

  • 00801741177156 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
LX18757405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177149

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X220MMX75CM
LUTONIX, INC.
LX187562205F
In Commercial Distribution

  • 00801741177149 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 220 Millimeter
LX187562205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177132

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X150MMX75CM
LUTONIX, INC.
LX187561505F
In Commercial Distribution

  • 00801741177132 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 6 Millimeter
LX187561505F

  • Peripheral angioplasty balloon catheter, drug-coated
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