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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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Upgrade Kit
LIGHTLAB IMAGING, INC.
Mobile System
In Commercial Distribution

  • 00812059021437 ()
C408662

  • Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
Integrated System E.2 Software
In Commercial Distribution

  • 00812059021390 ()
C408657

  • Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
OPTIS™ E.2 Software
In Commercial Distribution

  • 00812059021383 ()
C408656

  • Coronary optical coherence tomography system
Mobile Workstation
LIGHTLAB IMAGING, INC.
C408653
In Commercial Distribution

  • 00812059020126 ()
C408653

  • Coronary optical coherence tomography system
Installation Kit
LIGHTLAB IMAGING, INC.
Integrated System
In Commercial Distribution

  • 00812059020003 ()
C408654

  • Coronary optical coherence tomography system
CryoPRO™-5 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0442
In Commercial Distribution

  • B039SGI04421 ()
  • B039SGI04420 ()
  • B039SGI04429 ()


  • Blood cell freeze/thaw system
SynGenX®-1000 Disposable Cartridge
Thermogenesis Corp.
SGI-0305
In Commercial Distribution

  • B039SGI03050 ()
  • B039SGI03051 ()
  • B039SGI03059 ()


  • Umbilical cord blood collection set
SynGenX®-1000 Docking Station
Thermogenesis Corp.
SGI-0120-01
In Commercial Distribution

  • B039SGI0120010 ()
  • B039SGI0120011 ()


  • Noninvasive device battery charger
CryoPRO™-2 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0091
In Commercial Distribution

  • B039SGI00911 ()
  • B039SGI00910 ()
  • B039SGI00919 ()


  • Blood cell freeze/thaw system
SynGenX®-1000 Control Module
Thermogenesis Corp.
SGI-0046-01
In Commercial Distribution

  • B039SGI0046010 ()
  • B039SGI0046011 ()


  • Blood component separator, automated
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