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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 - 00801741098406

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x40mm
LUTONIX, INC.
BSCLX35130440
Not in Commercial Distribution

  • 00801741098406 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 40 Millimeter
BSCLX35130440

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098390

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x100mm
LUTONIX, INC.
BSCLX351304100
Not in Commercial Distribution

  • 00801741098390 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 100 Millimeter
BSCLX351304100

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098383

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm
LUTONIX, INC.
BSCLX3575460
In Commercial Distribution

  • 00801741098383 ()

  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
BSCLX3575460

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix 035 Drug Coated Balloon PTA Catheter - 00801741202575

Lutonix 035 12X60MMx75CM
LUTONIX, INC.
LX35751260V
In Commercial Distribution

  • 00801741202575 ()

  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 12 Millimeter
  • Catheter Length, 75 Centimeters
LX35751260V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199462

Lutonix 018 7X220MMX150CM
LUTONIX, INC.
LX1815072205F
In Commercial Distribution

  • 00801741199462 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 220 millimeter
LX1815072205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199455

Lutonix 018 7X150MMX150CM
LUTONIX, INC.
LX1815071505F
In Commercial Distribution

  • 00801741199455 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 150 millimeter
LX1815071505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199448

Lutonix 018 7X120MMX150CM
LUTONIX, INC.
LX1815071205F
In Commercial Distribution

  • 00801741199448 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 120 millimeter
LX1815071205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199431

Lutonix 018 7X100MMX150CM
LUTONIX, INC.
LX1815071005F
In Commercial Distribution

  • 00801741199431 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
LX1815071005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199424

Lutonix 018 7X80MMX150CM
LUTONIX, INC.
LX181507805F
In Commercial Distribution

  • 00801741199424 ()

  • Balloon Length, 80 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Diameter, 7 millimeter
LX181507805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199417

Lutonix 018 7X60MMX150CM
LUTONIX, INC.
LX181507605F
In Commercial Distribution

  • 00801741199417 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 150 centimeter
LX181507605F

  • Peripheral angioplasty balloon catheter, drug-coated
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