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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 - 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 - 00801741105012

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x150mm
LUTONIX, INC.
BSCLX351305150
Not in Commercial Distribution

  • 00801741105012 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
BSCLX351305150

  • 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 - 00801741098574

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm
LUTONIX, INC.
BSCLX3575680
In Commercial Distribution

  • 00801741098574 ()

  • Balloon Length, 80mm
  • Catheter Length, 75cm
  • Balloon Diameter, 6mm
BSCLX3575680

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098567

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm
LUTONIX, INC.
BSCLX3575660
In Commercial Distribution

  • 00801741098567 ()

  • Balloon Length, 60mm
  • Balloon Diameter, 6mm
  • Catheter Length, 75cm
BSCLX3575660

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098550

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x100mm
LUTONIX, INC.
BSCLX35756100
In Commercial Distribution

  • 00801741098550 ()

  • Balloon Length, 100mm
  • Catheter Length,75cm
  • Balloon Diameter, 6mm
BSCLX35756100

  • Peripheral angioplasty balloon catheter, drug-coated
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