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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 - 00801741088155

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x120mm
LUTONIX, INC.
LX35755120
In Commercial Distribution

  • 00801741088155 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
LX35755120

  • 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

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 - 00801741088100

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 75cm 4x100mm
LUTONIX, INC.
LX35754100
Not in Commercial Distribution

  • 00801741088100 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,100 Millimeter
  • Catheter Length,75 Centimeter
LX35754100

  • 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 - 00801741088070

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x80mm
LUTONIX, INC.
LX3575580
Not in Commercial Distribution

  • 00801741088070 ()

  • Catheter Length,75 Centimeter
  • Balloon Diameter,5 Millimeter
  • Balloon Length,80 Millimeter
LX3575580

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088063

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x80mm
LUTONIX, INC.
LX3575480
Not in Commercial Distribution

  • 00801741088063 ()

  • Balloon Length,80 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Diameter,4 Millimeter
LX3575480

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088056

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x60mm
LUTONIX, INC.
LX3575760
Not in Commercial Distribution

  • 00801741088056 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
LX3575760

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088049

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm
LUTONIX, INC.
LX3575660
Not in Commercial Distribution

  • 00801741088049 ()

  • Balloon Diameter,6 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,60 Millimeter
LX3575660

  • Peripheral angioplasty balloon catheter, drug-coated
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