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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 - 00801741098468

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x80mm
LUTONIX, INC.
BSCLX35130580
Not in Commercial Distribution

  • 00801741098468 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 5 Millimeter
BSCLX35130580

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098444

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x40mm
LUTONIX, INC.
BSCLX35130540
Not in Commercial Distribution

  • 00801741098444 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
BSCLX35130540

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098420

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x80mm
LUTONIX, INC.
BSCLX35130480
Not in Commercial Distribution

  • 00801741098420 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
BSCLX35130480

  • 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 - 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 - 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 - 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 - 00801741088360

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x80mm
LUTONIX, INC.
LX35100680
In Commercial Distribution

  • 00801741088360 ()

  • Balloon Diameter,6 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Length,80 Millimeter
LX35100680

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088346

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 4x80mm
LUTONIX, INC.
LX35100480
In Commercial Distribution

  • 00801741088346 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,80 Millimeter
  • Catheter Length,100 Centimeter
LX35100480

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088322

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x60mm
LUTONIX, INC.
LX35100660
In Commercial Distribution

  • 00801741088322 ()

  • Balloon Diameter,6 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,100 Centimeter
LX35100660

  • Peripheral angioplasty balloon catheter, drug-coated
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