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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 - 00801741088353

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 5x80mm
LUTONIX, INC.
LX35100580
In Commercial Distribution

  • 00801741088353 ()

  • Balloon Length,80 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Diameter,5 Millimeter
LX35100580

  • 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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

Lutonix ®Drug Coated Balloon - 00801741088032

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm
LUTONIX, INC.
LX3575560
Not in Commercial Distribution

  • 00801741088032 ()

  • Balloon Diameter,5 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,75 Centimeter
LX3575560

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088018

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x40mm
LUTONIX, INC.
LX3575740
Not in Commercial Distribution

  • 00801741088018 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
LX3575740

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741087998

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x40mm
LUTONIX, INC.
LX3575540
Not in Commercial Distribution

  • 00801741087998 ()

  • Balloon Diameter,5 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,40 Millimeter
LX3575540

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135798

Lutonix® AV Drug Coated Balloon PTA Catheter 12x40x100
LUTONIX, INC.
LX351001240V
In Commercial Distribution

  • 00801741135798 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 12 millimeter
LX351001240V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135781

Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x100
LUTONIX, INC.
LX351001220V
In Commercial Distribution

  • 00801741135781 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 12 millimeter
  • Balloon Length, 20 millimeter
LX351001220V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135774

Lutonix® AV Drug Coated Balloon PTA Catheter 10x60x100
LUTONIX, INC.
LX351001060V
In Commercial Distribution

  • 00801741135774 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 10 millimeter
LX351001060V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135750

Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x100
LUTONIX, INC.
LX351001020V
In Commercial Distribution

  • 00801741135750 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 10 millimeter
  • Balloon Length, 20 millimeter
LX351001020V

  • Peripheral angioplasty balloon catheter, drug-coated
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