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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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MONORAIL™ Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939733406020
In Commercial Distribution

  • 00191506046620 ()

  • Balloon Length: 60 Millimeter
  • Length: 200 Centimeter
  • Balloon Diameter: 4 Millimeter
H74939733406020

  • Peripheral angioplasty balloon catheter, drug-coated
MONORAIL™ Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939733404020
In Commercial Distribution

  • 00191506046613 ()

  • Balloon Diameter: 4 Millimeter
  • Length: 200 Centimeter
  • Balloon Length: 40 Millimeter
H74939733404020

  • Peripheral angioplasty balloon catheter, drug-coated
No Description
BIOMET MICROFIXATION, INC
46-0009
In Commercial Distribution

  • 00841036284619 ()
46-0009

  • Surgical flat-nosed pliers
LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x220mm
LUTONIX, INC.
LX351307220
Not in Commercial Distribution

  • 00801741178740 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX351307220

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 6x220mm
LUTONIX, INC.
LX351306220
Not in Commercial Distribution

  • 00801741178733 ()

  • Balloon Length, 220 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
LX351306220

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X150MMX130CM
LUTONIX, INC.
LX1813071505F
In Commercial Distribution

  • 00801741177767 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX1813071505F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X100MMX130CM
LUTONIX, INC.
LX1813071005F
In Commercial Distribution

  • 00801741177743 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 7 Millimeter
LX1813071005F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X60MMX130CM
LUTONIX, INC.
LX181307605F
In Commercial Distribution

  • 00801741177729 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
LX181307605F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX130CM
LUTONIX, INC.
LX1813062205F
In Commercial Distribution

  • 00801741177705 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 220 Millimeter
LX1813062205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX130CM
LUTONIX, INC.
LX1813061205F
In Commercial Distribution

  • 00801741177682 ()

  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX1813061205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X220MMX100CM
LUTONIX, INC.
LX1810072205F
In Commercial Distribution

  • 00801741177491 ()

  • Balloon Length, 220 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 7 Millimeter
LX1810072205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X150MMX100CM
LUTONIX, INC.
LX1810071505F
In Commercial Distribution

  • 00801741177484 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 7 Millimeter
LX1810071505F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X100MMX100CM
LUTONIX, INC.
LX1810071005F
In Commercial Distribution

  • 00801741177460 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
LX1810071005F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X80MMX100CM
LUTONIX, INC.
LX181007805F
In Commercial Distribution

  • 00801741177453 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 100 Centimeter
LX181007805F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X60MMX100CM
LUTONIX, INC.
LX181007605F
In Commercial Distribution

  • 00801741177446 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Length, 60 Millimeter
LX181007605F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X40MMX100CM
LUTONIX, INC.
LX181007405F
In Commercial Distribution

  • 00801741177439 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 40 Millimeter
LX181007405F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX100CM
LUTONIX, INC.
LX1810062205F
In Commercial Distribution

  • 00801741177422 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Length, 220 Millimeter
LX1810062205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X100MMX100CM
LUTONIX, INC.
LX1810061005F
In Commercial Distribution

  • 00801741177392 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 100 Millimeter
LX1810061005F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X60MMX100CM
LUTONIX, INC.
LX181006605F
In Commercial Distribution

  • 00801741177378 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Length, 60 Millimeter
LX181006605F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X220MMX100CM
LUTONIX, INC.
LX1810052205F
In Commercial Distribution

  • 00801741177354 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 220 Millimeter
LX1810052205F

  • Peripheral angioplasty balloon catheter, drug-coated
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® 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® 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® 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® 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® 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® 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® 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 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® 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® 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 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® 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 018 7X220MMX130CM
LUTONIX, INC.
LX1813072205F
In Commercial Distribution

  • 00801741177774 ()

  • Balloon Diameter, 7 Milimeter
  • Balloon Length, 220 Millimeter
  • Catheter Length, 130 Centimeter
LX1813072205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X120MMX130CM
LUTONIX, INC.
LX1813071205F
In Commercial Distribution

  • 00801741177750 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
LX1813071205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 7X80MMX130CM
LUTONIX, INC.
LX181307805F
In Commercial Distribution

  • 00801741177736 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX181307805F

  • Peripheral angioplasty balloon catheter, drug-coated
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