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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 - 00801741177415

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X150MMX100CM
LUTONIX, INC.
LX1810061505F
In Commercial Distribution

  • 00801741177415 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
LX1810061505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177408

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX100CM
LUTONIX, INC.
LX1810061205F
In Commercial Distribution

  • 00801741177408 ()

  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
LX1810061205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177392

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X100MMX100CM
LUTONIX, INC.
LX1810061005F
In Commercial Distribution

  • 00801741177392 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 100 Millimeter
LX1810061005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177385

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X80MMX100CM
LUTONIX, INC.
LX181006805F
In Commercial Distribution

  • 00801741177385 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 80 Millimeter
LX181006805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177378

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X60MMX100CM
LUTONIX, INC.
LX181006605F
In Commercial Distribution

  • 00801741177378 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Length, 60 Millimeter
LX181006605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177361

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X40MMX100CM
LUTONIX, INC.
LX181006405F
In Commercial Distribution

  • 00801741177361 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
LX181006405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177354

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X220MMX100CM
LUTONIX, INC.
LX1810052205F
In Commercial Distribution

  • 00801741177354 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 220 Millimeter
LX1810052205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177347

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX100CM
LUTONIX, INC.
LX1810051505F
In Commercial Distribution

  • 00801741177347 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 5 Millimeter
LX1810051505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177330

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX100CM
LUTONIX, INC.
LX1810051205F
In Commercial Distribution

  • 00801741177330 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
LX1810051205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177323

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X100MMX100CM
LUTONIX, INC.
LX1810051005F
In Commercial Distribution

  • 00801741177323 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 5 Millimeter
LX1810051005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177316

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X80MMX100CM
LUTONIX, INC.
LX181005805F
In Commercial Distribution

  • 00801741177316 ()

  • Balloon Length, 80 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
LX181005805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177309

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X60MMX100CM
LUTONIX, INC.
LX181005605F
In Commercial Distribution

  • 00801741177309 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 60 Millimeter
LX181005605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177293

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X40MMX100CM
LUTONIX, INC.
LX181005405F
In Commercial Distribution

  • 00801741177293 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 40 Millimeter
LX181005405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177286

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X220MMX100CM
LUTONIX, INC.
LX1810042204F
In Commercial Distribution

  • 00801741177286 ()

  • Balloon Diameter, 4 Millimeter
  • Balloon Length,220 Millimeter
  • Catheter Length, 100 Centimeter
LX1810042204F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177279

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X150MMX100CM
LUTONIX, INC.
LX1810041504F
In Commercial Distribution

  • 00801741177279 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 4 Millimeter
LX1810041504F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177262

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X120MMX100CM
LUTONIX, INC.
LX1810041204F
In Commercial Distribution

  • 00801741177262 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Length, 120 Millimeter
LX1810041204F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177255

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X100MMX100CM
LUTONIX, INC.
LX1810041004F
In Commercial Distribution

  • 00801741177255 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 4 Millimeter
LX1810041004F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177248

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X80MMX100CM
LUTONIX, INC.
LX181004804F
In Commercial Distribution

  • 00801741177248 ()

  • Balloon Length, 80 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 4 Millimeter
LX181004804F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177231

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X60MMX100CM
LUTONIX, INC.
LX181004604F
In Commercial Distribution

  • 00801741177231 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 60 Millimeter
LX181004604F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177224

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X40MMX100CM
LUTONIX, INC.
LX181004404F
In Commercial Distribution

  • 00801741177224 ()

  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 40, Millimeter
  • Catheter Length, 100, Centimeter
LX181004404F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177217

Lutonix 018 7X220MMX75CM
LUTONIX, INC.
LX187572205F
In Commercial Distribution

  • 00801741177217 ()

  • Catheter Length, 75cm
  • Balloon Diameter, 7mm
  • Balloon Length, 220mm
LX187572205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177200

LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X150MMX75CM
LUTONIX, INC.
LX187571505F
In Commercial Distribution

  • 00801741177200 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 150 Millimeter
LX187571505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177194

LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X120MMX75CM
LUTONIX, INC.
LX187571205F
In Commercial Distribution

  • 00801741177194 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 120 Millimeter
  • Catheter Length, 75 Centimeter
LX187571205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177187

LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X100MMX75CM
LUTONIX, INC.
LX187571005F
In Commercial Distribution

  • 00801741177187 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
LX187571005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177170

LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X80MMX75CM
LUTONIX, INC.
LX18757805F
In Commercial Distribution

  • 00801741177170 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
LX18757805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177163

LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X60MMX75CM
LUTONIX, INC.
LX18757605F
In Commercial Distribution

  • 00801741177163 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 60 Millimeter
LX18757605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177156

LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X40MMX75CM
LUTONIX, INC.
LX18757405F
In Commercial Distribution

  • 00801741177156 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
LX18757405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177149

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X220MMX75CM
LUTONIX, INC.
LX187562205F
In Commercial Distribution

  • 00801741177149 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 220 Millimeter
LX187562205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177132

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X150MMX75CM
LUTONIX, INC.
LX187561505F
In Commercial Distribution

  • 00801741177132 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 6 Millimeter
LX187561505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177125

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX75CM
LUTONIX, INC.
LX187561205F
In Commercial Distribution

  • 00801741177125 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 120 Millimeter
LX187561205F

  • Peripheral angioplasty balloon catheter, drug-coated
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