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® 035 Drug Coated Balloon PTA Catheter .035 75cm 4x100mm
LUTONIX, INC.
LX35754100
Not in Commercial Distribution

  • 00801741088100 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,100 Millimeter
  • Catheter Length,75 Centimeter
LX35754100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm
LUTONIX, INC.
LX3575680
Not in Commercial Distribution

  • 00801741088087 ()

  • Balloon Length,80 Millimeter
  • Balloon Diameter,6 Millimeter
  • Catheter Length,75 Centimeter
LX3575680

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x80mm
LUTONIX, INC.
LX3575580
Not in Commercial Distribution

  • 00801741088070 ()

  • Catheter Length,75 Centimeter
  • Balloon Diameter,5 Millimeter
  • Balloon Length,80 Millimeter
LX3575580

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x80mm
LUTONIX, INC.
LX3575480
Not in Commercial Distribution

  • 00801741088063 ()

  • Balloon Length,80 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Diameter,4 Millimeter
LX3575480

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x60mm
LUTONIX, INC.
LX3575760
Not in Commercial Distribution

  • 00801741088056 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
LX3575760

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm
LUTONIX, INC.
LX3575660
Not in Commercial Distribution

  • 00801741088049 ()

  • Balloon Diameter,6 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,60 Millimeter
LX3575660

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm
LUTONIX, INC.
LX3575560
Not in Commercial Distribution

  • 00801741088032 ()

  • Balloon Diameter,5 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,75 Centimeter
LX3575560

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm
LUTONIX, INC.
LX3575460
Not in Commercial Distribution

  • 00801741088025 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,75 Centimeter
LX3575460

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x40mm
LUTONIX, INC.
LX3575740
Not in Commercial Distribution

  • 00801741088018 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
LX3575740

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x40mm
LUTONIX, INC.
LX3575640
Not in Commercial Distribution

  • 00801741088001 ()

  • Balloon Length,40 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Diameter,6 Millimeter
LX3575640

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x40mm
LUTONIX, INC.
LX3575540
Not in Commercial Distribution

  • 00801741087998 ()

  • Balloon Diameter,5 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,40 Millimeter
LX3575540

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm
LUTONIX, INC.
LX3575440
Not in Commercial Distribution

  • 00801741087981 ()

  • Balloon Diameter,4 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,40 Millimeter
LX3575440

  • Peripheral angioplasty balloon catheter, drug-coated
PLIERS 836-062 REDUCTION PLIERS LOCKSCRW
MEDTRONIC SOFAMOR DANEK, INC.
836-062
In Commercial Distribution

  • 20721902034132 ()
  • 00721902034138 ()


  • 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 Drug Coated Balloon PTA Catheter, 6X80MMX130CM
LUTONIX, INC.
LX181306805F
In Commercial Distribution

  • 00801741177668 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX181306805F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X40MMX130CM
LUTONIX, INC.
LX181306405F
In Commercial Distribution

  • 00801741177644 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
LX181306405F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX130CM
LUTONIX, INC.
LX1813051505F
In Commercial Distribution

  • 00801741177620 ()

  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX1813051505F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX130CM
LUTONIX, INC.
LX1813051205F
In Commercial Distribution

  • 00801741177613 ()

  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX1813051205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X100MMX130CM
LUTONIX, INC.
LX1813051005F
In Commercial Distribution

  • 00801741177606 ()

  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
LX1813051005F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X80MMX130CM
LUTONIX, INC.
LX181305805F
In Commercial Distribution

  • 00801741177590 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 80 Millimeter
LX181305805F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X60MMX130CM
LUTONIX, INC.
LX181305605F
In Commercial Distribution

  • 00801741177583 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
LX181305605F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X40MMX130CM
LUTONIX, INC.
LX181305405F
In Commercial Distribution

  • 00801741177576 ()

  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 40 Millimeter
  • Catheter Length, 130 Centimeter
LX181305405F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X220MMX130CM
LUTONIX, INC.
LX1813042204F
In Commercial Distribution

  • 00801741177569 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 220 Millimeter
LX1813042204F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X150MMX130CM
LUTONIX, INC.
LX1813041504F
In Commercial Distribution

  • 00801741177552 ()

  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX1813041504F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X120MMX130CM
LUTONIX, INC.
LX1813041204F
In Commercial Distribution

  • 00801741177545 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
LX1813041204F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X100MMX130CM
LUTONIX, INC.
LX1813041004F
In Commercial Distribution

  • 00801741177538 ()

  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX1813041004F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X60MMX130CM
LUTONIX, INC.
LX181304604F
In Commercial Distribution

  • 00801741177514 ()

  • Balloon Length, 60 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
LX181304604F

  • 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 7X120MMX100CM
LUTONIX, INC.
LX1810071205F
In Commercial Distribution

  • 00801741177477 ()

  • Balloon Diameter, 7 Milimeter
  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
LX1810071205F

  • 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, 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 5X120MMX100CM
LUTONIX, INC.
LX1810051205F
In Commercial Distribution

  • 00801741177330 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
LX1810051205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X100MMX100CM
LUTONIX, INC.
LX1810051005F
In Commercial Distribution

  • 00801741177323 ()

  • Catheter Length, 100 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 5 Millimeter
LX1810051005F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X80MMX100CM
LUTONIX, INC.
LX181005805F
In Commercial Distribution

  • 00801741177316 ()

  • Balloon Length, 80 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
LX181005805F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X60MMX100CM
LUTONIX, INC.
LX181005605F
In Commercial Distribution

  • 00801741177309 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 60 Millimeter
LX181005605F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X40MMX100CM
LUTONIX, INC.
LX181005405F
In Commercial Distribution

  • 00801741177293 ()

  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 40 Millimeter
LX181005405F

  • Peripheral angioplasty balloon catheter, drug-coated
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® 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® 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® 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
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