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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 - 00801741105050

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x120mm
LUTONIX, INC.
BSCLX35756120
In Commercial Distribution

  • 00801741105050 ()

  • Balloon Length
  • Catheter Length
BSCLX35756120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741105043

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x120mm
LUTONIX, INC.
BSCLX35755120
In Commercial Distribution

  • 00801741105043 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
BSCLX35755120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741105036

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x120mm
LUTONIX, INC.
BSCLX35754120
In Commercial Distribution

  • 00801741105036 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX35754120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741105029

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm
LUTONIX, INC.
BSCLX351306150
Not in Commercial Distribution

  • 00801741105029 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX351306150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741105012

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x150mm
LUTONIX, INC.
BSCLX351305150
Not in Commercial Distribution

  • 00801741105012 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
BSCLX351305150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741105005

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x150mm
LUTONIX, INC.
BSCLX351304150
Not in Commercial Distribution

  • 00801741105005 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
BSCLX351304150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741104992

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm
LUTONIX, INC.
BSCLX351306120
Not in Commercial Distribution

  • 00801741104992 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
BSCLX351306120

  • Peripheral angioplasty balloon catheter, drug-coated

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 - 00801741088773

LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x150mm
LUTONIX, INC.
LX351307150
Not in Commercial Distribution

  • 00801741088773 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX351307150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088766

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm
LUTONIX, INC.
LX351306150
Not in Commercial Distribution

  • 00801741088766 ()

  • Balloon Diameter
  • Balloon Length
  • Catheter Length
LX351306150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088759

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x150mm
LUTONIX, INC.
LX351305150
Not in Commercial Distribution

  • 00801741088759 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
LX351305150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088742

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x150mm
LUTONIX, INC.
LX351304150
Not in Commercial Distribution

  • 00801741088742 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
LX351304150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088735

LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x120mm
LUTONIX, INC.
LX351307120
In Commercial Distribution

  • 00801741088735 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 120 Millimeter
LX351307120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088728

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm
LUTONIX, INC.
LX351306120
Not in Commercial Distribution

  • 00801741088728 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
LX351306120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088711

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x120mm
LUTONIX, INC.
LX351305120
Not in Commercial Distribution

  • 00801741088711 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
LX351305120

  • 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 - 00801741088698

LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm 7x100mm
LUTONIX, INC.
LX351307100
Not in Commercial Distribution

  • 00801741088698 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
LX351307100

  • 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 - 00801741088667

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x100mm
LUTONIX, INC.
LX351304100
Not in Commercial Distribution

  • 00801741088667 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,100 Millimeter
  • Catheter Length,130 Centimeter
LX351304100

  • 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 - 00801741088636

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 5x80mm
LUTONIX, INC.
LX35130580
Not in Commercial Distribution

  • 00801741088636 ()

  • Balloon Diameter,5 Millimeter
  • Balloon Length,80 Millimeter
  • Catheter Length,130 Centimeter
LX35130580

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088629

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x80mm
LUTONIX, INC.
LX35130480
Not in Commercial Distribution

  • 00801741088629 ()

  • Balloon Length,80 Millimeter
  • Balloon Diameter,4 Millimeter
  • Catheter Length,130 Centimeter
LX35130480

  • 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 - 00801741088582

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x60mm
LUTONIX, INC.
LX35130460
Not in Commercial Distribution

  • 00801741088582 ()

  • Balloon Diameter,4 Millimeter
  • Catheter Length,130 Centimeter
  • Balloon Length,60 Millimeter
LX35130460

  • 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 - 00801741088568

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x40mm
LUTONIX, INC.
LX35130640
Not in Commercial Distribution

  • 00801741088568 ()

  • Catheter Length,130 Centimeter
  • Balloon Length,40 Millimeter
  • Balloon Diameter,6 Millimeter
LX35130640

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088551

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 5x40mm
LUTONIX, INC.
LX35130540
Not in Commercial Distribution

  • 00801741088551 ()

  • Catheter Length,130 Centimeter
  • Balloon Length,40 Millimeter
  • Balloon Diameter,5 Millimeter
LX35130540

  • 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 - 00801741088483

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 6x150mm
LUTONIX, INC.
LX351006150
In Commercial Distribution

  • 00801741088483 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
LX351006150

  • 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 - 00801741088469

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 4x150mm
LUTONIX, INC.
LX351004150
In Commercial Distribution

  • 00801741088469 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
LX351004150

  • 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

Lutonix® Drug Coated Balloon - 00801741088407

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x100mm
LUTONIX, INC.
LX351006100
In Commercial Distribution

  • 00801741088407 ()

  • Balloon Length,100 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Diameter,6 Millimeter
LX351006100

  • Peripheral angioplasty balloon catheter, drug-coated
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