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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® 018 Drug Coated Balloon PTA Catheter 6X40MMX75CM
LUTONIX, INC.
LX18756405F
In Commercial Distribution

  • 00801741177088 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 6 Millimeter
LX18756405F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X150MMX75CM
LUTONIX, INC.
LX187551505F
In Commercial Distribution

  • 00801741177064 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 150 Millimeter
LX187551505F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 7mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513072205F
In Commercial Distribution

  • 00801741163470 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX3513072205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 7mm x 150mm x 130cm, 5F
LUTONIX, INC.
LX3513071505F
In Commercial Distribution

  • 00801741163463 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
LX3513071505F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 7mm x 120mm x 130cm, 5F
LUTONIX, INC.
LX3513071205F
In Commercial Distribution

  • 00801741163456 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
LX3513071205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 7mm x 100mm x 130cm, 5F
LUTONIX, INC.
LX3513071005F
In Commercial Distribution

  • 00801741163449 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
LX3513071005F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 7mm x 80mm x 130cm, 5F
LUTONIX, INC.
LX351307805F
In Commercial Distribution

  • 00801741163432 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
LX351307805F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 6mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513062205F
In Commercial Distribution

  • 00801741163425 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 220 Millimeter
LX3513062205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 5mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513052205F
In Commercial Distribution

  • 00801741163418 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX3513052205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 4mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513042205F
In Commercial Distribution

  • 00801741163401 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX3513042205F

  • Peripheral angioplasty balloon catheter, drug-coated
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