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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 - 00801741184697

Lutonix 018 6X300MMX100CM
LUTONIX, INC.
LX1810063005F
In Commercial Distribution

  • 00801741184697 ()

  • Balloon Length, 300 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
LX1810063005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184680

Lutonix 018 5X300MMX100CM
LUTONIX, INC.
LX1810053005F
In Commercial Distribution

  • 00801741184680 ()

  • Balloon Length, 300 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 100 Centimeter
LX1810053005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184673

Lutonix 018 4X300MMX100CM
LUTONIX, INC.
LX1810043005F
In Commercial Distribution

  • 00801741184673 ()

  • Balloon Length, 300 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 4 Millimeter
LX1810043005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741178740

LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x220mm
LUTONIX, INC.
LX351307220
Not in Commercial Distribution

  • 00801741178740 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX351307220

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741178733

LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 6x220mm
LUTONIX, INC.
LX351306220
Not in Commercial Distribution

  • 00801741178733 ()

  • Balloon Length, 220 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
LX351306220

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177774

Lutonix 018 7X220MMX130CM
LUTONIX, INC.
LX1813072205F
In Commercial Distribution

  • 00801741177774 ()

  • Balloon Diameter, 7 Milimeter
  • Balloon Length, 220 Millimeter
  • Catheter Length, 130 Centimeter
LX1813072205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177767

Lutonix 018 7X150MMX130CM
LUTONIX, INC.
LX1813071505F
In Commercial Distribution

  • 00801741177767 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX1813071505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177750

Lutonix 018 7X120MMX130CM
LUTONIX, INC.
LX1813071205F
In Commercial Distribution

  • 00801741177750 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
LX1813071205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177743

Lutonix 018 7X100MMX130CM
LUTONIX, INC.
LX1813071005F
In Commercial Distribution

  • 00801741177743 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 7 Millimeter
LX1813071005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177736

Lutonix 018 7X80MMX130CM
LUTONIX, INC.
LX181307805F
In Commercial Distribution

  • 00801741177736 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX181307805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177729

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X60MMX130CM
LUTONIX, INC.
LX181307605F
In Commercial Distribution

  • 00801741177729 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
LX181307605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177712

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X40MMX130CM
LUTONIX, INC.
LX181307405F
In Commercial Distribution

  • 00801741177712 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX181307405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177705

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX130CM
LUTONIX, INC.
LX1813062205F
In Commercial Distribution

  • 00801741177705 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 220 Millimeter
LX1813062205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177699

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X150MMX130CM
LUTONIX, INC.
LX1813061505F
In Commercial Distribution

  • 00801741177699 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX1813061505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177682

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX130CM
LUTONIX, INC.
LX1813061205F
In Commercial Distribution

  • 00801741177682 ()

  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX1813061205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177675

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X100MMX130CM
LUTONIX, INC.
LX1813061005F
In Commercial Distribution

  • 00801741177675 ()

  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX1813061005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177668

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X80MMX130CM
LUTONIX, INC.
LX181306805F
In Commercial Distribution

  • 00801741177668 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX181306805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177651

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X60MMX130CM
LUTONIX, INC.
LX181306605F
In Commercial Distribution

  • 00801741177651 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 6 Millimeter
LX181306605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177644

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X40MMX130CM
LUTONIX, INC.
LX181306405F
In Commercial Distribution

  • 00801741177644 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
LX181306405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177637

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X220MMX130CM
LUTONIX, INC.
LX1813052205F
In Commercial Distribution

  • 00801741177637 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 220 Millimeter
LX1813052205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177620

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX130CM
LUTONIX, INC.
LX1813051505F
In Commercial Distribution

  • 00801741177620 ()

  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX1813051505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177613

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX130CM
LUTONIX, INC.
LX1813051205F
In Commercial Distribution

  • 00801741177613 ()

  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX1813051205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177606

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X100MMX130CM
LUTONIX, INC.
LX1813051005F
In Commercial Distribution

  • 00801741177606 ()

  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
LX1813051005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177590

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X80MMX130CM
LUTONIX, INC.
LX181305805F
In Commercial Distribution

  • 00801741177590 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 80 Millimeter
LX181305805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177583

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X60MMX130CM
LUTONIX, INC.
LX181305605F
In Commercial Distribution

  • 00801741177583 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
LX181305605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177576

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X40MMX130CM
LUTONIX, INC.
LX181305405F
In Commercial Distribution

  • 00801741177576 ()

  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 40 Millimeter
  • Catheter Length, 130 Centimeter
LX181305405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177569

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X220MMX130CM
LUTONIX, INC.
LX1813042204F
In Commercial Distribution

  • 00801741177569 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 220 Millimeter
LX1813042204F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177552

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X150MMX130CM
LUTONIX, INC.
LX1813041504F
In Commercial Distribution

  • 00801741177552 ()

  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX1813041504F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177545

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X120MMX130CM
LUTONIX, INC.
LX1813041204F
In Commercial Distribution

  • 00801741177545 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
LX1813041204F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177538

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X100MMX130CM
LUTONIX, INC.
LX1813041004F
In Commercial Distribution

  • 00801741177538 ()

  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX1813041004F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177521

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X80MMX130CM
LUTONIX, INC.
LX181304804F
In Commercial Distribution

  • 00801741177521 ()

  • Balloon Length, 80 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
LX181304804F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177514

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X60MMX130CM
LUTONIX, INC.
LX181304604F
In Commercial Distribution

  • 00801741177514 ()

  • Balloon Length, 60 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
LX181304604F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177507

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X40MMX130CM
LUTONIX, INC.
LX181304404F
In Commercial Distribution

  • 00801741177507 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 4 Millimeter
LX181304404F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177491

Lutonix 018 7X220MMX100CM
LUTONIX, INC.
LX1810072205F
In Commercial Distribution

  • 00801741177491 ()

  • Balloon Length, 220 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 7 Millimeter
LX1810072205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177484

Lutonix 018 7X150MMX100CM
LUTONIX, INC.
LX1810071505F
In Commercial Distribution

  • 00801741177484 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 7 Millimeter
LX1810071505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177477

Lutonix 018 7X120MMX100CM
LUTONIX, INC.
LX1810071205F
In Commercial Distribution

  • 00801741177477 ()

  • Balloon Diameter, 7 Milimeter
  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
LX1810071205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177460

Lutonix 018 7X100MMX100CM
LUTONIX, INC.
LX1810071005F
In Commercial Distribution

  • 00801741177460 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
LX1810071005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® Drug Coated Balloon - 00801741177453

Lutonix 018 7X80MMX100CM
LUTONIX, INC.
LX181007805F
In Commercial Distribution

  • 00801741177453 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 100 Centimeter
LX181007805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177446

LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X60MMX100CM
LUTONIX, INC.
LX181007605F
In Commercial Distribution

  • 00801741177446 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Length, 60 Millimeter
LX181007605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177439

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X40MMX100CM
LUTONIX, INC.
LX181007405F
In Commercial Distribution

  • 00801741177439 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 40 Millimeter
LX181007405F

  • Peripheral angioplasty balloon catheter, drug-coated
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