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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® AV Drug Coated Balloon PTA Catheter 10x60x40
LUTONIX, INC.
LX35401060V
Not in Commercial Distribution

  • 00801741135279 ()

  • Balloon Diameter, 10 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 40 centimeter
LX35401060V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x40x40
LUTONIX, INC.
LX35401040V
Not in Commercial Distribution

  • 00801741135262 ()

  • Catheter Length, 40 centimeter
  • Balloon Length, 40 millimeter
  • Balloon Diameter, 10 millimeter
LX35401040V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x40
LUTONIX, INC.
LX35401020V
In Commercial Distribution

  • 00801741135255 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 10 millimeter
  • Catheter Length, 40 centimeter
LX35401020V

  • Peripheral angioplasty balloon catheter, drug-coated
CTAG CMDS 26MMX21MMX10CM 20Fr
W. L. Gore & Associates, Inc.
TGM262110
In Commercial Distribution

  • 00733132646913 ()

  • Outer Diameter: 26 Millimeter
  • Length: 10 Centimeter
  • Outer Diameter: 21 Millimeter
TGM262110

  • Descending thoracic aorta endovascular stent-graft
CTAG CMDS 40MMX40MMX10CM 22Fr
W. L. Gore & Associates, Inc.
TGMR404010
In Commercial Distribution

  • 00733132646838 ()

  • Length: 10 Centimeter
  • Outer Diameter: 40 Millimeter
  • Catheter Gauge: 22 French
TGMR404010

  • Descending thoracic aorta endovascular stent-graft
CTAG CMDS 37MMX37MMX10CM 22Fr
W. L. Gore & Associates, Inc.
TGMR373710
In Commercial Distribution

  • 00733132646807 ()

  • Catheter Gauge: 22 French
  • Outer Diameter: 37 Millimeter
  • Length: 10 Centimeter
TGMR373710

  • Descending thoracic aorta endovascular stent-graft
CTAG CMDS 31MMX31MMX10CM 20Fr
W. L. Gore & Associates, Inc.
TGMR313110
In Commercial Distribution

  • 00733132646777 ()

  • Length: 10 Centimeter
  • Outer Diameter: 31 Millimeter
  • Catheter Gauge: 20 French
TGMR313110

  • Descending thoracic aorta endovascular stent-graft
VIABAHN BX BALLOON EXP ENDO 10mmX79mm 8Fr135cmCath Heparin
W. L. Gore & Associates, Inc.
BXA107902A
In Commercial Distribution

  • 00733132637645 ()

  • Length: 79 Millimeter
  • Outer Diameter: 10 Millimeter
  • Catheter Gauge: 8 French
  • Catheter Working Length: 135 CM
BXA107902A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN BX BALLOON EXP ENDO 10mmX79mm 8Fr 80cmCath Heparin
W. L. Gore & Associates, Inc.
BXA107901A
In Commercial Distribution

  • 00733132637638 ()

  • Catheter Working Length: 80 CM
  • Catheter Gauge: 8 French
  • Outer Diameter: 10 Millimeter
  • Length: 79 Millimeter
BXA107901A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN BX BALLOON EXP ENDO 10mmX29mm 8Fr135cmCath Heparin
W. L. Gore & Associates, Inc.
BXA102902A
In Commercial Distribution

  • 00733132637621 ()

  • Length: 29 Millimeter
  • Outer Diameter: 10 Millimeter
  • Catheter Gauge: 8 French
  • Catheter Working Length: 135 CM
BXA102902A

  • Peripheral artery endovascular stent-graft, drug-coated
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