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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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HL7 Software for Sleepware G3, Web
Respironics, Inc.
3.1
In Commercial Distribution

  • 00606959038967 ()
1117948

  • Clinical laboratory information system
Grael v2 System with PSG software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001771 ()
9028-0002-02

  • Polysomnograph
Somte Recording System Compumedics, no Software
COMPUMEDICS LIMITED
Somte
In Commercial Distribution

  • 09342451001733 ()
9012-0003-01

  • Polysomnograph
Somte PSG v2 System, No software
COMPUMEDICS LIMITED
Somte PSG v2
In Commercial Distribution

  • 09342451001368 ()
9023-0002-01

  • Polysomnograph
Grael EEG v2 System - no software
COMPUMEDICS LIMITED
Grael EEG
In Commercial Distribution

  • 09342451001252 ()
9028-0003-02

  • Electroencephalograph
CUSTOM SOUND SUITE 4.1 SOFTWARE - CAM
COCHLEAR LIMITED
Z494179
In Commercial Distribution

  • 09321502029469 ()
Z494179

  • Audiometric/hearing device software
Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution

  • 09321502065764 ()
P2006651

  • Audiometric/hearing device software
Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software
KARL STORZ SCB Software Upgrade "VOICE1"
Karl Storz GmbH & Co. KG
20090001-40
In Commercial Distribution

  • 04048551228517 ()


  • Operating room audiovisual data/device management system application software
PULSE Software Package including IOM, iG
Nuvasive, Inc.
8000104
In Commercial Distribution

  • 00195377099013 ()


  • Orthopaedic stereotactic surgery system
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