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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

FO NX Nail System - 09353903009139

2.0 NX Extremity Nail 24 mm 1/pkg
FIELD ORTHOPAEDICS PTY LTD
APN000192
In Commercial Distribution

  • 09353903009139 ()
NXNC-2024/1

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Validate - 00850011135372

VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Tg Set: Thyroglobulin (Tg) TU Set: T-Uptake (TU)
Lgc Clinical Diagnostics, Inc.
908bc
In Commercial Distribution

  • 00850011135372 ()


  • Thyroglobulin IVD, control
  • Multiple thyroid hormone uptake (T-uptake) IVD, control

KILT BLOCKER - 00840331272796

KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .35mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
S8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272796 ()


  • Radiation shielding apron

KILT BLOCKER - 00840331272734

KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .5mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
R8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272734 ()


  • Radiation shielding apron
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