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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 - 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 - 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 - 00801741177002

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® Drug Coated Balloon - 00801741176982

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X120MMX75CM
LUTONIX, INC.
LX187541204F
In Commercial Distribution

  • 00801741176982 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 120 Millimeter
LX187541204F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741176968

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X80MMX75CM
LUTONIX, INC.
LX18754804F
In Commercial Distribution

  • 00801741176968 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 80 Millimeter
LX18754804F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741176951

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® Drug Coated Balloon - 00801741176944

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

LUTONIX® Drug Coated Balloon - 00801741163470

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® Drug Coated Balloon - 00801741163463

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® Drug Coated Balloon - 00801741163456

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® Drug Coated Balloon - 00801741163449

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® Drug Coated Balloon - 00801741163432

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® Drug Coated Balloon - 00801741163425

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® Drug Coated Balloon - 00801741163418

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® Drug Coated Balloon - 00801741163401

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

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135798

Lutonix® AV Drug Coated Balloon PTA Catheter 12x40x100
LUTONIX, INC.
LX351001240V
In Commercial Distribution

  • 00801741135798 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 12 millimeter
LX351001240V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135781

Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x100
LUTONIX, INC.
LX351001220V
In Commercial Distribution

  • 00801741135781 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 12 millimeter
  • Balloon Length, 20 millimeter
LX351001220V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135774

Lutonix® AV Drug Coated Balloon PTA Catheter 10x60x100
LUTONIX, INC.
LX351001060V
In Commercial Distribution

  • 00801741135774 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 10 millimeter
LX351001060V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135767

Lutonix® AV Drug Coated Balloon PTA Catheter 10x40x100
LUTONIX, INC.
LX351001040V
In Commercial Distribution

  • 00801741135767 ()

  • Balloon Diameter, 10 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
LX351001040V

  • Peripheral angioplasty balloon catheter, drug-coated
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