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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 4X60MMX75CM
LUTONIX, INC.
LX18754604F
In Commercial Distribution

  • 00801741176951 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
LX18754604F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 018 4X40MMX75CM
LUTONIX, INC.
LX18754404F
In Commercial Distribution

  • 00801741176944 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 40 Millimeter
LX18754404F

  • Peripheral angioplasty balloon catheter, drug-coated
CYSTO PACK
Cardinal Health 200, LLC
SOP45CPCUA
In Commercial Distribution

  • 50197106545162 ()
  • 10197106545164 ()
SOP45CPCUA

  • Urological surgical procedure kit, non-medicated, single-use
No Description
Kossel Medtech (Suzhou) Co., Ltd.
KNC225010
In Commercial Distribution

  • 06971591765675 ()


  • Coronary angioplasty balloon catheter, perfusing
CYSTO PACK
Cardinal Health 200, LLC
SOT24CPCRA
In Commercial Distribution

  • 50197106555673 ()
  • 10197106555675 ()
SOT24CPCRA

  • Urological surgical procedure kit, non-medicated, single-use
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 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 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 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 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
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