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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® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x40mm
LUTONIX, INC.
LX3575640
Not in Commercial Distribution

  • 00801741088001 ()

  • Balloon Length,40 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Diameter,6 Millimeter
LX3575640

  • Peripheral angioplasty balloon catheter, drug-coated
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 .035" 75cm 4x40mm
LUTONIX, INC.
LX3575440
Not in Commercial Distribution

  • 00801741087981 ()

  • Balloon Diameter,4 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,40 Millimeter
LX3575440

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX75CM
LUTONIX, INC.
LX187551205F
In Commercial Distribution

  • 00801741177057 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 120 Millimeter
LX187551205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X100MMX75CM
LUTONIX, INC.
LX187551005F
In Commercial Distribution

  • 00801741177040 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 100 Millimeter
LX187551005F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X80MMX75CM
LUTONIX, INC.
LX18755805F
In Commercial Distribution

  • 00801741177033 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 5 Millimeter
LX18755805F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X60MMX75CM
LUTONIX, INC.
LX18755605F
In Commercial Distribution

  • 00801741177026 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 60 Millimeter
LX18755605F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X40MMX75CM
LUTONIX, INC.
LX18755405F
In Commercial Distribution

  • 00801741177019 ()

  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 40 Millimeter
  • Catheter Length, 75 Centimeter
LX18755405F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X220MMX75CM
LUTONIX, INC.
LX187542204F
In Commercial Distribution

  • 00801741177002 ()

  • Balloon Length, 220 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
LX187542204F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x100mm
LUTONIX, INC.
BSCLX35756100
In Commercial Distribution

  • 00801741098550 ()

  • Balloon Length, 100mm
  • Catheter Length,75cm
  • Balloon Diameter, 6mm
BSCLX35756100

  • Peripheral angioplasty balloon catheter, drug-coated
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