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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Drill Stop
LINKSPINE, INC.
80-2531
In Commercial Distribution

  • 00817329024545 ()
80-2531

  • Trans-facet-screw internal spinal fixation system, non-sterile
Drill
LINKSPINE, INC.
80-2530
In Commercial Distribution

  • 00817329024538 ()
80-2530

  • Trans-facet-screw internal spinal fixation system, non-sterile
Facet Screw Screwdriver
LINKSPINE, INC.
80-2520
In Commercial Distribution

  • 00817329024521 ()
80-2520

  • Trans-facet-screw internal spinal fixation system, non-sterile
Trocar Stylet
LINKSPINE, INC.
80-2511
In Commercial Distribution

  • 00817329024514 ()
80-2511

  • Trans-facet-screw internal spinal fixation system, non-sterile
Trocar Stylet
LINKSPINE, INC.
80-2510
In Commercial Distribution

  • 00817329024507 ()
80-2510

  • Trans-facet-screw internal spinal fixation system, non-sterile
Dilator Handle
LINKSPINE, INC.
80-2505
In Commercial Distribution

  • 00817329024491 ()
80-2505

  • Trans-facet-screw internal spinal fixation system, non-sterile
Dilator 3
LINKSPINE, INC.
80-2503
In Commercial Distribution

  • 00817329024484 ()
80-2503

  • Trans-facet-screw internal spinal fixation system, non-sterile
Dilator 2
LINKSPINE, INC.
80-2502
In Commercial Distribution

  • 00817329024477 ()
80-2502

  • Trans-facet-screw internal spinal fixation system, non-sterile
Dilator 1
LINKSPINE, INC.
80-2501
In Commercial Distribution

  • 00817329024460 ()
80-2501

  • Trans-facet-screw internal spinal fixation system, non-sterile
LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117019109 ()
LSPSAB2

  • HLA class I & II antibody screening IVD, kit, multiplex
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