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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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Monaco - 00858164002169

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002169 ()


  • Radiation therapy software

Monaco - 00858164002152

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002152 ()


  • Radiation therapy software

XiO - 00858164002114

No Description
ELEKTA, INC.
XiO
Not in Commercial Distribution

  • 00858164002114 ()


  • Radiation therapy software

Monaco - 00858164002046

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002046 ()


  • Radiation therapy software

Atlas-Based Autosegmentation - 00858164002039

No Description
ELEKTA, INC.
Atlas-Based Autosegmentation
Not in Commercial Distribution

  • 00858164002039 ()


  • Radiation therapy software

Cognitive Assessment Battery (CAB)® PRO - 00860009958104

A collection of neuropsychological tests for health professionals and researchers. The assessment measures cognitive function and performs a complete cognitive screening, allowing users to quickly, conveniently, and accurately assess the well-being and cognitive profile of patients and research participants. Applicable via in-person consultation, in a laboratory setting, and remotely.
Cognifit, Inc.
PRO
In Commercial Distribution

  • 00860009958104 ()


  • Cognitive assessment software

Speech Vitals - Cognition - 00860009693401

No Description
Aural Analytics, Inc.
SVCOG
Not in Commercial Distribution

  • 00860009693401 ()


  • Cognitive assessment software

Neurotrack Cognitive Assessment Battery - 00860009484504

Neurotrack’s exam is a computerized cognitive exam delivered via mobile device or browser, intended to detect and track cognitive impairment in patients with existing cognitive impairment, subjective memory loss, or healthy individuals. The user will interact with the exam battery on a screen. Using visual cues, the user will touch the screen, trackpad or mouse to make a selection. Successful completion of the exam battery relies on use of the hands and eyes. The device may be used by the patient in the home, or in a health clinic with or without supervision. The results are reviewed by a health care provider trained in nervous system conditions. Neurotrack’s digital cognitive assessment suite is not a stand-alone diagnostic tool and does not identify the absence or presence of any illness, condition, or disease. While Neurotrack’s digital cognitive assessment suite can be self-administered, any interpretation of scores should be discussed with a healthcare provider.
Neurotrack Technologies, Inc.
1.1.0
In Commercial Distribution

  • 00860009484504 ()


  • Cognitive assessment software

ML 830® - 00859626006282

SL Console
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-003
In Commercial Distribution

  • 00859626006282 ()
ML-830-07-003

  • Laser application software

ML 830® - 00859626006190

DC Console Activation Card
MICROLIGHT CORPORATION OF AMERICA
ML-830-04-002
In Commercial Distribution

  • 00859626006190 ()
ML-830-04-002

  • Laser application software
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