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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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BluEX Lumbar Expandable Cage System - 08809986465726

BluEX-A (24 X 32 X 16 mm, 8°)
L&K BIOMED CO. ,LTD.
BA2432-1608S
In Commercial Distribution

  • 08809986465726 ()


  • Metallic spinal interbody fusion cage

BluEX Lumbar Expandable Cage System - 08809986465719

BluEX-A (24 X 32 X 13 mm, 8°)
L&K BIOMED CO. ,LTD.
BA2432-1308S
In Commercial Distribution

  • 08809986465719 ()


  • Metallic spinal interbody fusion cage

BluEX Lumbar Expandable Cage System - 08809986465702

BluEX-A (24 X 32 X 10 mm, 8°)
L&K BIOMED CO. ,LTD.
BA2432-1008S
In Commercial Distribution

  • 08809986465702 ()


  • Metallic spinal interbody fusion cage

BluEX Lumbar Expandable Cage System - 08809986465696

BluEX-A (24 X 32 X 07 mm, 0°)
L&K BIOMED CO. ,LTD.
BA2432-0700S
In Commercial Distribution

  • 08809986465696 ()


  • Metallic spinal interbody fusion cage

Band Assemblies - 00190707134587

Elite.022 LL6 Conv Dbl BuccalTube Epic 24
ORTHO ORGANIZERS, INC.
900-12406E-24
In Commercial Distribution

  • 00190707134587 ()


  • Orthodontic metal band

Band Assemblies - 00190707133245

Elite.022 LR6 Double BuccalTube Epic/Cleat 24
ORTHO ORGANIZERS, INC.
900-123061E-24
In Commercial Distribution

  • 00190707133245 ()


  • Orthodontic metal band

FemTrak Femoral Venous Cannula - 00690103180138

Femoral Venous Cannula
Edwards Lifesciences LLC
FTV024
In Commercial Distribution

  • 00690103180138 ()

  • 24 Fr. (8.0 mm) x 68 cm (26.8")
FTV024

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral

FemTrak Femoral Venous Cannula - 00690103180121

Femoral Venous Cannula
Edwards Lifesciences LLC
FTV020
In Commercial Distribution

  • 00690103180121 ()

  • 20 Fr. (6.7 mm) x 55 cm (21.6")
FTV020

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral

Fem-Flex II Femoral Arterial Cannula - 00690103168365

FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII020AS
In Commercial Distribution

  • 00690103168365 ()

  • 20 Fr. (6.7 mm) x 15 cm (6")
FEMII020AS

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral

Fem-Flex II Femoral Arterial Cannula - 00690103168358

FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII018AS
In Commercial Distribution

  • 00690103168358 ()

  • 18 Fr. (6.0 mm) x 15 cm (6")
FEMII018AS

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
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