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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 - 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
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