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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 - 00801741123269

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x60mm 5 French
LUTONIX, INC.
LX351306605F
In Commercial Distribution

  • 00801741123269 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 60 Millimeter
LX351306605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123252

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x40mm 5 French
LUTONIX, INC.
LX351306405F
In Commercial Distribution

  • 00801741123252 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
LX351306405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123245

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x150mm 5 French
LUTONIX, INC.
LX3513051505F
In Commercial Distribution

  • 00801741123245 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX3513051505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123238

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x120mm 5 French
LUTONIX, INC.
LX3513051205F
In Commercial Distribution

  • 00801741123238 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
LX3513051205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123221

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x100mm 5 French
LUTONIX, INC.
LX3513051005F
In Commercial Distribution

  • 00801741123221 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 100 Millimeter
LX3513051005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123214

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x80mm 5 French
LUTONIX, INC.
LX351305805F
In Commercial Distribution

  • 00801741123214 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX351305805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123207

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x60mm 5 French
LUTONIX, INC.
LX351305605F
In Commercial Distribution

  • 00801741123207 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
LX351305605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123191

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x40mm 5 French
LUTONIX, INC.
LX351305405F
In Commercial Distribution

  • 00801741123191 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX351305405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123184

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x150mm 5 French
LUTONIX, INC.
LX3513041505F
In Commercial Distribution

  • 00801741123184 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
LX3513041505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123177

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x120mm 5 French
LUTONIX, INC.
LX3513041205F
In Commercial Distribution

  • 00801741123177 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 4 Millimeter
LX3513041205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123160

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x100mm 5 French
LUTONIX, INC.
LX3513041005F
In Commercial Distribution

  • 00801741123160 ()

  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
LX3513041005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123153

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x80mm 5 French
LUTONIX, INC.
LX351304805F
In Commercial Distribution

  • 00801741123153 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX351304805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123146

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x60mm 5 French
LUTONIX, INC.
LX351304605F
In Commercial Distribution

  • 00801741123146 ()

  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX351304605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123139

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x40mm 5 French
LUTONIX, INC.
LX351304405F
In Commercial Distribution

  • 00801741123139 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
LX351304405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122934

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x60mm 5 French
LUTONIX, INC.
LX35757605F
In Commercial Distribution

  • 00801741122934 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 7 millimeter
LX35757605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122927

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x40mm 5 French
LUTONIX, INC.
LX35757405F
In Commercial Distribution

  • 00801741122927 ()

  • Balloon Diameter, 7 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
LX35757405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122910

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x150mm 5 French
LUTONIX, INC.
LX357561505F
In Commercial Distribution

  • 00801741122910 ()

  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 150 millimeter
LX357561505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122903

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x120mm 5 French
LUTONIX, INC.
LX357561205F
In Commercial Distribution

  • 00801741122903 ()

  • Catheter Length, 75 centimeter
  • Balloon Length, 120 millimeter
  • Balloon Diameter, 6 millimeter
LX357561205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122897

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x100mm 5 French
LUTONIX, INC.
LX357561005F
Not in Commercial Distribution

  • 00801741122897 ()

  • Balloon Length, 100 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
LX357561005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122880

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm 5 French
LUTONIX, INC.
LX35756805F
Not in Commercial Distribution

  • 00801741122880 ()

  • Balloon Length, 80 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
LX35756805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122873

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm 5 French
LUTONIX, INC.
LX35756605F
Not in Commercial Distribution

  • 00801741122873 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
LX35756605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122866

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x40mm 5 French
LUTONIX, INC.
LX35756405F
Not in Commercial Distribution

  • 00801741122866 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 6 millimeter
  • Balloon Length, 40 millimeter
LX35756405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122859

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x150mm 5 French
LUTONIX, INC.
LX357551505F
In Commercial Distribution

  • 00801741122859 ()

  • Balloon Diameter, 5 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 150 millimeter
LX357551505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122842

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x120mm 5 French
LUTONIX, INC.
LX357551205F
In Commercial Distribution

  • 00801741122842 ()

  • Catheter Length, 75 centimeter
  • Balloon Length, 120 millimeter
  • Balloon Diameter, 5 millimeter
LX357551205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122835

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x100mm 5 French
LUTONIX, INC.
LX357551005F
Not in Commercial Distribution

  • 00801741122835 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
LX357551005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122828

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x80mm 5 French
LUTONIX, INC.
LX35755805F
Not in Commercial Distribution

  • 00801741122828 ()

  • Balloon Length, 80 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
LX35755805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122811

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm 5 French
LUTONIX, INC.
LX35755605F
Not in Commercial Distribution

  • 00801741122811 ()

  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
LX35755605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122804

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x40mm 5 French
LUTONIX, INC.
LX35755405F
Not in Commercial Distribution

  • 00801741122804 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 75 Centimeter
LX35755405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122798

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x150mm 5 French
LUTONIX, INC.
LX357541505F
In Commercial Distribution

  • 00801741122798 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
LX357541505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122774

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x120mm 5 French
LUTONIX, INC.
LX357541205F
In Commercial Distribution

  • 00801741122774 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 120 Millimeter
LX357541205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122767

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x100mm 5 French
LUTONIX, INC.
LX357541005F
Not in Commercial Distribution

  • 00801741122767 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 4 Millimeter
LX357541005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122750

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x80mm 5 French
LUTONIX, INC.
LX35754805F
Not in Commercial Distribution

  • 00801741122750 ()

  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 80 Millimeter
  • Catheter Length, 75 Centimeter
LX35754805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122743

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm 5 French
LUTONIX, INC.
LX35754605F
Not in Commercial Distribution

  • 00801741122743 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 60 Millimeter
LX35754605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122736

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm 5 French
LUTONIX, INC.
LX35754405F
Not in Commercial Distribution

  • 00801741122736 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
LX35754405F

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098574

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm
LUTONIX, INC.
BSCLX3575680
In Commercial Distribution

  • 00801741098574 ()

  • Balloon Length, 80mm
  • Catheter Length, 75cm
  • Balloon Diameter, 6mm
BSCLX3575680

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098567

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm
LUTONIX, INC.
BSCLX3575660
In Commercial Distribution

  • 00801741098567 ()

  • Balloon Length, 60mm
  • Balloon Diameter, 6mm
  • Catheter Length, 75cm
BSCLX3575660

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098550

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x100mm
LUTONIX, INC.
BSCLX35756100
In Commercial Distribution

  • 00801741098550 ()

  • Balloon Length, 100mm
  • Catheter Length,75cm
  • Balloon Diameter, 6mm
BSCLX35756100

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098543

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x80mm
LUTONIX, INC.
BSCLX3575580
In Commercial Distribution

  • 00801741098543 ()

  • Balloon Length, 80mm
  • Catheter Length, 75cm
  • Balloon Diameter, 5mm
BSCLX3575580

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098536

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm
LUTONIX, INC.
BSCLX3575560
In Commercial Distribution

  • 00801741098536 ()

  • Balloon Length, 60mm
  • Balloon Diameter, 5mm
  • Catheter Length, 75cm
BSCLX3575560

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098529

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x100mm
LUTONIX, INC.
BSCLX35755100
In Commercial Distribution

  • 00801741098529 ()

  • Balloon Diameter, 5mm
  • Catheter Length, 75cm
  • Balloon Length, 100mm
BSCLX35755100

  • Peripheral angioplasty balloon catheter, drug-coated
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