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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 - 00801741098413

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x60mm
LUTONIX, INC.
BSCLX35130460
Not in Commercial Distribution

  • 00801741098413 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 4 Millimeter
BSCLX35130460

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098406

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x40mm
LUTONIX, INC.
BSCLX35130440
Not in Commercial Distribution

  • 00801741098406 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 40 Millimeter
BSCLX35130440

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098390

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x100mm
LUTONIX, INC.
BSCLX351304100
Not in Commercial Distribution

  • 00801741098390 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 100 Millimeter
BSCLX351304100

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098383

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm
LUTONIX, INC.
BSCLX3575460
In Commercial Distribution

  • 00801741098383 ()

  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
BSCLX3575460

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122910

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x150mm 5 French
LUTONIX, INC.
LX357561505F
In Commercial Distribution

  • 00801741122910 ()

  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 150 millimeter
LX357561505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122903

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x120mm 5 French
LUTONIX, INC.
LX357561205F
In Commercial Distribution

  • 00801741122903 ()

  • Catheter Length, 75 centimeter
  • Balloon Length, 120 millimeter
  • Balloon Diameter, 6 millimeter
LX357561205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122897

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x100mm 5 French
LUTONIX, INC.
LX357561005F
Not in Commercial Distribution

  • 00801741122897 ()

  • Balloon Length, 100 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
LX357561005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122880

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm 5 French
LUTONIX, INC.
LX35756805F
Not in Commercial Distribution

  • 00801741122880 ()

  • Balloon Length, 80 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
LX35756805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122873

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm 5 French
LUTONIX, INC.
LX35756605F
Not in Commercial Distribution

  • 00801741122873 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
LX35756605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122866

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x40mm 5 French
LUTONIX, INC.
LX35756405F
Not in Commercial Distribution

  • 00801741122866 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 6 millimeter
  • Balloon Length, 40 millimeter
LX35756405F

  • Peripheral angioplasty balloon catheter, drug-coated
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