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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 - 00801741088407

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x100mm
LUTONIX, INC.
LX351006100
In Commercial Distribution

  • 00801741088407 ()

  • Balloon Length,100 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Diameter,6 Millimeter
LX351006100

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088391

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 5x100mm
LUTONIX, INC.
LX351005100
In Commercial Distribution

  • 00801741088391 ()

  • Balloon Diameter,5 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Length,100 Millimeter
LX351005100

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088384

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 4x100mm
LUTONIX, INC.
LX351004100
In Commercial Distribution

  • 00801741088384 ()

  • Catheter Length,100 Centimeter
  • Balloon Diameter,4 Millimeter
  • Balloon Length,100 Millimeter
LX351004100

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088360

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x80mm
LUTONIX, INC.
LX35100680
In Commercial Distribution

  • 00801741088360 ()

  • Balloon Diameter,6 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Length,80 Millimeter
LX35100680

  • Peripheral angioplasty balloon catheter, drug-coated

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 - 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

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 - 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

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 - 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
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