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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 - 00801741088346

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 4x80mm
LUTONIX, INC.
LX35100480
In Commercial Distribution

  • 00801741088346 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,80 Millimeter
  • Catheter Length,100 Centimeter
LX35100480

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088339

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 7x60mm
LUTONIX, INC.
LX35100760
In Commercial Distribution

  • 00801741088339 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 7 Millimeter
LX35100760

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088322

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x60mm
LUTONIX, INC.
LX35100660
In Commercial Distribution

  • 00801741088322 ()

  • Balloon Diameter,6 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,100 Centimeter
LX35100660

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088315

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 5x60mm
LUTONIX, INC.
LX35100560
In Commercial Distribution

  • 00801741088315 ()

  • Balloon Length,60 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Diameter,5 Millimeter
LX35100560

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088308

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 4x60mm
LUTONIX, INC.
LX35100460
In Commercial Distribution

  • 00801741088308 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,100 Centimeter
LX35100460

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088292

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 7x40mm
LUTONIX, INC.
LX35100740
In Commercial Distribution

  • 00801741088292 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
LX35100740

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088285

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x40mm
LUTONIX, INC.
LX35100640
In Commercial Distribution

  • 00801741088285 ()

  • Balloon Length,40 Millimeter
  • Balloon Diameter,6 Millimeter
  • Catheter Length,100 Centimeter
LX35100640

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088278

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 5x40mm
LUTONIX, INC.
LX35100540
In Commercial Distribution

  • 00801741088278 ()

  • Balloon Diameter,5 Millimeter
  • Balloon Length,40 Millimeter
  • Catheter Length,100 Centimeter
LX35100540

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088261

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 4x40mm
LUTONIX, INC.
LX35100440
In Commercial Distribution

  • 00801741088261 ()

  • Catheter Length,100 Centimeter
  • Balloon Diameter,4 Millimeter
  • Balloon Length,40 Millimeter
LX35100440

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088209

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x150mm
LUTONIX, INC.
LX35756150
In Commercial Distribution

  • 00801741088209 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
LX35756150

  • Peripheral angioplasty balloon catheter, drug-coated
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