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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 - 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

Lutonix® Drug Coated Balloon - 00801741098543

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x80mm
LUTONIX, INC.
BSCLX3575580
In Commercial Distribution

  • 00801741098543 ()

  • Balloon Length, 80mm
  • Catheter Length, 75cm
  • Balloon Diameter, 5mm
BSCLX3575580

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098536

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm
LUTONIX, INC.
BSCLX3575560
In Commercial Distribution

  • 00801741098536 ()

  • Balloon Length, 60mm
  • Balloon Diameter, 5mm
  • Catheter Length, 75cm
BSCLX3575560

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098529

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x100mm
LUTONIX, INC.
BSCLX35755100
In Commercial Distribution

  • 00801741098529 ()

  • Balloon Diameter, 5mm
  • Catheter Length, 75cm
  • Balloon Length, 100mm
BSCLX35755100

  • Peripheral angioplasty balloon catheter, drug-coated

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
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