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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 - 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

LUTONIX® Drug Coated Balloon - 00801741088193

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x150mm
LUTONIX, INC.
LX35755150
In Commercial Distribution

  • 00801741088193 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
LX35755150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088186

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x150mm
LUTONIX, INC.
LX35754150
In Commercial Distribution

  • 00801741088186 ()

  • Balloon Length
  • Balloon Diameter
  • Catheter Length
LX35754150

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088162

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x120mm
LUTONIX, INC.
LX35756120
In Commercial Distribution

  • 00801741088162 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
LX35756120

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088148

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x120mm
LUTONIX, INC.
LX35754120
In Commercial Distribution

  • 00801741088148 ()

  • Catheter Length
  • Balloon Length
  • Balloon Diameter
LX35754120

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088124

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 75cm 6x100mm
LUTONIX, INC.
LX35756100
Not in Commercial Distribution

  • 00801741088124 ()

  • Balloon Length,100 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Diameter,6 Millimeter
LX35756100

  • Peripheral angioplasty balloon catheter, drug-coated
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