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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 - 00801741098512

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x100mm
LUTONIX, INC.
BSCLX35754100
In Commercial Distribution

  • 00801741098512 ()

  • Balloon Diameter, 4mm
  • Catheter Length, 75cm
  • Balloon Length, 100mm
BSCLX35754100

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098505

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x80mm
LUTONIX, INC.
BSCLX35130680
Not in Commercial Distribution

  • 00801741098505 ()

  • Balloon Length, 80mm
  • Catheter Length, 130cm
  • Balloon Diameter,6mm
BSCLX35130680

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098499

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x60mm
LUTONIX, INC.
BSCLX35130660
Not in Commercial Distribution

  • 00801741098499 ()

  • Balloon Length, 60mm
  • Catheter Length, 130cm
  • Balloon Diameter, 6mm
BSCLX35130660

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098482

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x40mm
LUTONIX, INC.
BSCLX35130640
Not in Commercial Distribution

  • 00801741098482 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 6 Millimeter
BSCLX35130640

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098475

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x100mm
LUTONIX, INC.
BSCLX351306100
Not in Commercial Distribution

  • 00801741098475 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 100 Millimeter
BSCLX351306100

  • Peripheral angioplasty balloon catheter, drug-coated

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 - 00801741098451

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x60mm
LUTONIX, INC.
BSCLX35130560
Not in Commercial Distribution

  • 00801741098451 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 5 Millimeter
BSCLX35130560

  • 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 - 00801741098437

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x100mm
LUTONIX, INC.
BSCLX351305100
Not in Commercial Distribution

  • 00801741098437 ()

  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
BSCLX351305100

  • 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
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