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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 - 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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