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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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BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x40mm 5 French
LUTONIX, INC.
BSLX351304405F
Not in Commercial Distribution

  • 00801741123733 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Diameter, 4 millimeter
BSLX351304405F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x60mm 5 French
LUTONIX, INC.
BSLX35757605F
Not in Commercial Distribution

  • 00801741123528 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 75 centimeter
BSLX35757605F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x40mm 5 French
LUTONIX, INC.
BSLX35757405F
Not in Commercial Distribution

  • 00801741123511 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 40 millimeter
BSLX35757405F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x150mm 5 French
LUTONIX, INC.
BSLX357561505F
In Commercial Distribution

  • 00801741123504 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 150 millimeter
  • Catheter Length, 75 centimeter
BSLX357561505F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x120mm 5 French
LUTONIX, INC.
BSLX357561205F
In Commercial Distribution

  • 00801741123498 ()

  • Catheter Length, 75 centimeter
  • Balloon Length, 120 millimeter
  • Balloon Diameter, 6 millimeter
BSLX357561205F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x100mm 5 French
LUTONIX, INC.
BSLX357561005F
Not in Commercial Distribution

  • 00801741123481 ()

  • Balloon Diameter, 6 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 100 millimeter
BSLX357561005F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm 5 French
LUTONIX, INC.
BSLX35756805F
Not in Commercial Distribution

  • 00801741123474 ()

  • Balloon Length, 80 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 6 millimeter
BSLX35756805F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm 5 French
LUTONIX, INC.
BSLX35756605F
Not in Commercial Distribution

  • 00801741123467 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 6 millimeter
BSLX35756605F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x40mm 5 French
LUTONIX, INC.
BSLX35756405F
Not in Commercial Distribution

  • 00801741123450 ()

  • Catheter Length, 75 centimeter
  • Balloon Length, 40 millimeter
  • Balloon Diameter, 6 millimeter
BSLX35756405F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x150mm 5 French
LUTONIX, INC.
BSLX357551505F
In Commercial Distribution

  • 00801741123443 ()

  • Balloon Diameter, 5 millimeter
  • Balloon Length, 150 millimeter
  • Catheter Length, 75 centimeter
BSLX357551505F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x120mm 5 French
LUTONIX, INC.
BSLX357551205F
In Commercial Distribution

  • 00801741123436 ()

  • Balloon Diameter, 5 millimeter
  • Balloon Length, 120 millimeter
  • Catheter Length, 75 centimeter
BSLX357551205F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x100mm 5 French
LUTONIX, INC.
BSLX357551005F
Not in Commercial Distribution

  • 00801741123429 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
BSLX357551005F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x80mm 5 French
LUTONIX, INC.
BSLX35755805F
Not in Commercial Distribution

  • 00801741123412 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 80 millimeter
BSLX35755805F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm 5 French
LUTONIX, INC.
BSLX35755605F
Not in Commercial Distribution

  • 00801741123405 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length, 75 centimeter
BSLX35755605F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x40mm 5 French
LUTONIX, INC.
BSLX35755405F
Not in Commercial Distribution

  • 00801741123399 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 40 millimeter
BSLX35755405F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x150mm 5 French
LUTONIX, INC.
BSLX357541505F
In Commercial Distribution

  • 00801741123382 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 150 millimeter
  • Catheter Length, 75 centimeter
BSLX357541505F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x120mm 5 French
LUTONIX, INC.
BSLX357541205F
In Commercial Distribution

  • 00801741123375 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 120 millimeter
BSLX357541205F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x100mm 5 French
LUTONIX, INC.
BSLX357541005F
Not in Commercial Distribution

  • 00801741123368 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 100 millimeter
BSLX357541005F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x80mm 5 French
LUTONIX, INC.
BSLX35754805F
Not in Commercial Distribution

  • 00801741123351 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 80 millimeter
  • Catheter Length, 75 centimeter
BSLX35754805F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm 5 French
LUTONIX, INC.
BSLX35754605F
Not in Commercial Distribution

  • 00801741123344 ()

  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
BSLX35754605F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm 5 French
LUTONIX, INC.
BSLX35754405F
Not in Commercial Distribution

  • 00801741123337 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
BSLX35754405F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm 5 French
LUTONIX, INC.
LX351307605F
In Commercial Distribution

  • 00801741123320 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 7 Millimeter
LX351307605F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm 5 French
LUTONIX, INC.
LX351307405F
In Commercial Distribution

  • 00801741123313 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
LX351307405F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm 5 French
LUTONIX, INC.
LX3513061505F
In Commercial Distribution

  • 00801741123306 ()

  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX3513061505F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm 5 French
LUTONIX, INC.
LX3513061205F
In Commercial Distribution

  • 00801741123290 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 6 Millimeter
LX3513061205F

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x100mm 5 French
LUTONIX, INC.
LX3513061005F
In Commercial Distribution

  • 00801741123283 ()

  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
LX3513061005F

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