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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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SOFTWARE APPLICATION, TOTAL SHOULDER PLANNING
Exactech, Inc.
L00041
In Commercial Distribution

  • 10885862518767 ()
L00041

  • Robotic surgical navigation system
Software, Delivery Analysis, Version 1.2.2
ACCURAY INCORPORATED
1064315
In Commercial Distribution

  • M65810643150 ()
NA

  • Linear accelerator system
Software, Delivery Analysis, Version 1.2.1
ACCURAY INCORPORATED
1062213
In Commercial Distribution

  • M65810622130 ()
NA

  • Linear accelerator system
Software, Delivery Analysis, Version 1.2
ACCURAY INCORPORATED
1057375
In Commercial Distribution

  • M65810573750 ()
NA

  • Linear accelerator system
Software, Delivery Analysis, Version 1.1
ACCURAY INCORPORATED
1052591
In Commercial Distribution

  • M65810525910 ()
NA

  • Linear accelerator system
Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit
CD WITH 9.02 software version
BIOMERIEUX , INC.
9.02.0
In Commercial Distribution

  • 03573026609399 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated
EASYMAG SOFTWARE V2.1 : virtual reference
BIOMERIEUX SA
2.1
In Commercial Distribution

  • 03573026448301 ()


  • Nucleic acid sample preparation instrument IVD
Monarch™ Software Laptop v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032760201050 ()


  • CT system application software
Monarch™ Software Cart v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032750201050 ()


  • Robotic surgical system application software
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