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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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PillCam (TM) Desktop Software v9.7 Upgrade
Given Imaging, Inc.
FGS-0803
In Commercial Distribution

  • 10884521845923 ()


  • Video capsule endoscopy system application software
Siemens UNITY 3 SOFTWARE (USB STICK)
Ws Audiology Usa, Inc.
UNITY 3 SOFTWARE (USB STICK)
Not in Commercial Distribution

  • 04046355641976 ()
10823966

  • Audiometric/hearing aid tester
BD Pyxis CIISafe (Software v9.X)
CAREFUSION 303, INC.
SW-CII-SAFE-V9
In Commercial Distribution

  • 10885403513725 ()


  • Anaesthesia cabinet
PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSS01
In Commercial Distribution

  • 00195278341129 ()
5870857

  • Bedside information system application software
PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only
PULSE Software Package including IOM, iG
Nuvasive, Inc.
8000104
In Commercial Distribution

  • 00195377099013 ()


  • Orthopaedic stereotactic surgery system
Knee Software Package, ART 2.0.1 Add-on
Omni Life Science, Inc.
NS-27007
In Commercial Distribution

  • 00841690194538 ()
NS-27007

  • Instrument tray, reusable
Knee Software Package, ART 2.1 Add-on
Omni Life Science, Inc.
NS-27008
In Commercial Distribution

  • 00841690194521 ()
NS-27008

  • Instrument tray, reusable
Knee Software Package, ART 2.2 Add-on
Omni Life Science, Inc.
NS-27009
In Commercial Distribution

  • 00841690194514 ()
NS-27009

  • Instrument tray, reusable
Knee Software Package, ART 2.3 Add-on
Omni Life Science, Inc.
NS-27010
In Commercial Distribution

  • 00841690194507 ()
NS-27010

  • Instrument tray, reusable
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