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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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VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
BIOMERIEUX , INC.
9.01.1
In Commercial Distribution

  • 03573026619060 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
BriefCase is a radiological computer aided triage and notification software device. Software version 3.0.0 for CSF triage
AIDOC MEDICAL LTD
3.0.0
Not in Commercial Distribution

  • 07290018052037 ()


  • Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software device. Software version 2.0.0 for PE triage
AIDOC MEDICAL LTD
2.0.0
Not in Commercial Distribution

  • 07290018052020 ()


  • Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software device. Software version 1.1.0.0 for ICH triage.
AIDOC MEDICAL LTD
1.1.0.0
Not in Commercial Distribution

  • 07290018052013 ()


  • Radiology DICOM image processing application software
customized SOLOASSIST II for Dexter, incl. Power supply and supply cable
Aktormed GmbH
212499
In Commercial Distribution

  • 04260463844993 ()
212499

  • Surgical camera holder
Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control’s proprietary algorithm uses period start date information entered by the user to provide predictions of “high risk days” and “low risk days” for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between 18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy.
BioWink GmbH
1
In Commercial Distribution

  • 04260749840008 ()


  • Self-care monitoring/reporting software
No Description
EPIC SYSTEMS CORPORATION
4
In Commercial Distribution

  • 00850053416002 ()


  • Blood bank information system application software
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH).
Infervision US Inc
1.1.0.0
In Commercial Distribution

  • 00850003095011 ()


  • Diagnostic x-ray digital imaging system workstation
  • X-ray image interpretive software
Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25203
In Commercial Distribution

  • 05020583252035 ()


  • Blood bank information system
Information System Version 4, Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25202
In Commercial Distribution

  • 05020583252028 ()


  • Blood bank information system
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