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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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Open CC Str 400
Medynus, Inc
CRT-55400
In Commercial Distribution

  • 00810088653162 ()
CRT-55400

  • Bone-screw internal spinal fixation system, non-sterile
Open CC Str 300
Medynus, Inc
CRT-55300
In Commercial Distribution

  • 00810088653155 ()
CRT-55300

  • Bone-screw internal spinal fixation system, non-sterile
Open CC Str 150
Medynus, Inc
CRT-55150
In Commercial Distribution

  • 00810088653094 ()
CRT-55150

  • Bone-screw internal spinal fixation system, non-sterile
LIF INSERTER SLEEVE C-C
ALPHATEC SPINE, INC.
255-140-50
In Commercial Distribution

  • 00190376364490 ()


  • Metallic spinal interbody fusion cage
Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush
Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush
Pressure PreventionBlank Product Description: Balanced Aire APP Mattress Custom
Drive Devilbiss Healthcare
BA9600-CUSTOM
In Commercial Distribution

  • 00822383577173 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
DreamMapper Mobile App Android, North America Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054226 ()
1101479

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android, Asia- Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054240 ()
1127960

  • Self-care monitoring/reporting software
Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable
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