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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 - 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 - 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 - 00801741088117

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 75cm 5x100mm
LUTONIX, INC.
LX35755100
Not in Commercial Distribution

  • 00801741088117 ()

  • Balloon Diameter,5 Millimeter
  • Balloon Length,100 Millimeter
  • Catheter Length,75 Centimeter
LX35755100

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088087

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm
LUTONIX, INC.
LX3575680
Not in Commercial Distribution

  • 00801741088087 ()

  • Balloon Length,80 Millimeter
  • Balloon Diameter,6 Millimeter
  • Catheter Length,75 Centimeter
LX3575680

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088025

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm
LUTONIX, INC.
LX3575460
Not in Commercial Distribution

  • 00801741088025 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,75 Centimeter
LX3575460

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088001

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x40mm
LUTONIX, INC.
LX3575640
Not in Commercial Distribution

  • 00801741088001 ()

  • Balloon Length,40 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Diameter,6 Millimeter
LX3575640

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741087981

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm
LUTONIX, INC.
LX3575440
Not in Commercial Distribution

  • 00801741087981 ()

  • Balloon Diameter,4 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,40 Millimeter
LX3575440

  • Peripheral angioplasty balloon catheter, drug-coated
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