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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 - 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 - 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 - 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

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 - 00801741088704

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x120mm
LUTONIX, INC.
LX351304120
Not in Commercial Distribution

  • 00801741088704 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
LX351304120

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088681

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x100mm
LUTONIX, INC.
LX351306100
Not in Commercial Distribution

  • 00801741088681 ()

  • Balloon Length,100 Millimeter
  • Catheter Length,130 Centimeter
  • Balloon Diameter,6 Millimeter
LX351306100

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088674

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 5x100mm
LUTONIX, INC.
LX351305100
Not in Commercial Distribution

  • 00801741088674 ()

  • Balloon Diameter,5 Millimeter
  • Catheter Length,130 Centimeter
  • Balloon Length,100 Millimeter
LX351305100

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088650

LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x80mm
LUTONIX, INC.
LX35130780
In Commercial Distribution

  • 00801741088650 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX35130780

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088643

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x80mm
LUTONIX, INC.
LX35130680
Not in Commercial Distribution

  • 00801741088643 ()

  • Balloon Length,80 Millimeter
  • Catheter Length,130 Centimeter
  • Balloon Diameter,6 Millimeter
LX35130680

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088612

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm
LUTONIX, INC.
LX35130760
Not in Commercial Distribution

  • 00801741088612 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 7 Millimeter
LX35130760

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088605

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x60mm
LUTONIX, INC.
LX35130660
Not in Commercial Distribution

  • 00801741088605 ()

  • Balloon Diameter,6 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,130 Centimeter
LX35130660

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088599

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 5x60mm
LUTONIX, INC.
LX35130560
Not in Commercial Distribution

  • 00801741088599 ()

  • Catheter Length,130 Centimeter
  • Balloon Diameter,5 Millimeter
  • Balloon Length,60 Millimeter
LX35130560

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088575

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm
LUTONIX, INC.
LX35130740
Not in Commercial Distribution

  • 00801741088575 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 40 Millimeter
  • Catheter Length, 130 Centimeter
LX35130740

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088544

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x40mm
LUTONIX, INC.
LX35130440
Not in Commercial Distribution

  • 00801741088544 ()

  • Catheter Length,130 Centimeter
  • Balloon Diameter,4 Millimeter
  • Balloon Length,40 Millimeter
LX35130440

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088476

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 5x150mm
LUTONIX, INC.
LX351005150
In Commercial Distribution

  • 00801741088476 ()

  • Balloon Diameter
  • Balloon Length
  • Catheter Length
LX351005150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088445

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 6x120mm
LUTONIX, INC.
LX351006120
In Commercial Distribution

  • 00801741088445 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
LX351006120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088438

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 5x120mm
LUTONIX, INC.
LX351005120
In Commercial Distribution

  • 00801741088438 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
LX351005120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088421

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 4x120mm
LUTONIX, INC.
LX351004120
In Commercial Distribution

  • 00801741088421 ()

  • Catheter Length
  • Balloon Length
  • Balloon Diameter
LX351004120

  • Peripheral angioplasty balloon catheter, drug-coated
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