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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 - 00801741177163

LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X60MMX75CM
LUTONIX, INC.
LX18757605F
In Commercial Distribution

  • 00801741177163 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 60 Millimeter
LX18757605F

  • 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 - 00801741177149

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X220MMX75CM
LUTONIX, INC.
LX187562205F
In Commercial Distribution

  • 00801741177149 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 220 Millimeter
LX187562205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177132

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X150MMX75CM
LUTONIX, INC.
LX187561505F
In Commercial Distribution

  • 00801741177132 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 6 Millimeter
LX187561505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177125

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX75CM
LUTONIX, INC.
LX187561205F
In Commercial Distribution

  • 00801741177125 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 120 Millimeter
LX187561205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177118

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X100MMX75CM
LUTONIX, INC.
LX187561005F
In Commercial Distribution

  • 00801741177118 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 100 Millimeter
LX187561005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177101

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X80MMX75CM
LUTONIX, INC.
LX18756805F
In Commercial Distribution

  • 00801741177101 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 80 Millimeter
LX18756805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177095

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X60MMX75CM
LUTONIX, INC.
LX18756605F
In Commercial Distribution

  • 00801741177095 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 6 Millimeter
LX18756605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177088

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® Drug Coated Balloon - 00801741177071

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X220MMX75CM
LUTONIX, INC.
LX187552205F
In Commercial Distribution

  • 00801741177071 ()

  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 220 Millimeter
  • Catheter Length, 75 Centimeter
LX187552205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177064

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® Drug Coated Balloon - 00801741177057

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® Drug Coated Balloon - 00801741177040

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® Drug Coated Balloon - 00801741177033

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® Drug Coated Balloon - 00801741177026

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® Drug Coated Balloon - 00801741177019

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® 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 - 00801741176999

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X150MMX75CM
LUTONIX, INC.
LX187541504F
In Commercial Distribution

  • 00801741176999 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 4 Millimeter
LX187541504F

  • 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 - 00801741176975

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X100MMX75CM
LUTONIX, INC.
LX187541004F
In Commercial Distribution

  • 00801741176975 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 100 Millimeter
LX187541004F

  • 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 ® 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

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135743

Lutonix® AV Drug Coated Balloon PTA Catheter 9x60x100
LUTONIX, INC.
LX35100960V
In Commercial Distribution

  • 00801741135743 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 9 millimeter
  • Balloon Length, 60 millimeter
LX35100960V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135729

Lutonix® AV Drug Coated Balloon PTA Catheter 9x20x100
LUTONIX, INC.
LX35100920V
In Commercial Distribution

  • 00801741135729 ()

  • Balloon Length, 20 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 9 millimeter
LX35100920V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135712

Lutonix® AV Drug Coated Balloon PTA Catheter 8x60x100
LUTONIX, INC.
LX35100860V
In Commercial Distribution

  • 00801741135712 ()

  • Balloon Diameter, 8 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
LX35100860V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135705

Lutonix® AV Drug Coated Balloon PTA Catheter 8x40x100
LUTONIX, INC.
LX35100840V
In Commercial Distribution

  • 00801741135705 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 8 millimeter
LX35100840V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135699

Lutonix® AV Drug Coated Balloon PTA Catheter 8x20x100
LUTONIX, INC.
LX35100820V
In Commercial Distribution

  • 00801741135699 ()

  • Catheter Length, 100 centimeter
  • Balloon Length, 20 millimeter
  • Balloon Diameter, 8 millimeter
LX35100820V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135682

Lutonix® AV Drug Coated Balloon PTA Catheter 7x60x100
LUTONIX, INC.
LX35100760V
Not in Commercial Distribution

  • 00801741135682 ()

  • Catheter Length, 100 centimeter
  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
LX35100760V

  • Peripheral angioplasty balloon catheter, drug-coated
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