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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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No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For iPhone 7 Plus
In Commercial Distribution

  • 07290016650228 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy J2
In Commercial Distribution

  • 07290016650211 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Xiaomi mi 5
Not in Commercial Distribution

  • 07290016650204 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy S8 plus
In Commercial Distribution

  • 07290016650198 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy S8
In Commercial Distribution

  • 07290016650181 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Huawei Honor 6
In Commercial Distribution

  • 07290016650174 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Huawei Mate 9
In Commercial Distribution

  • 07290016650167 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Xiaomi Note 4
In Commercial Distribution

  • 07290016650150 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For LG G6
In Commercial Distribution

  • 07290016650143 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For LG G5
In Commercial Distribution

  • 07290016650136 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Iphone 6 plus/ 6s plus/ 7 plus
In Commercial Distribution

  • 07290016650112 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 7 Edge
In Commercial Distribution

  • 07290016650105 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 7
Not in Commercial Distribution

  • 07290016650082 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 6
In Commercial Distribution

  • 07290016650075 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For I-Phone 7
In Commercial Distribution

  • 07290016650068 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For I-Phone 6
In Commercial Distribution

  • 07290016650051 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
CLEW MEDICAL LTD
4.8
In Commercial Distribution

  • 07290018852002 ()


  • Clinical management support software
INTELLIO TABLET
Smith & Nephew, Inc.
72205455
In Commercial Distribution

  • 00885556813683 ()
72205455

  • Operating room audiovisual data/device management system application software
Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045517585 ()
ASY-17964

  • Laboratory instrument/analyser application software IVD
Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045517097 ()
ASY-14304

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045515062 ()
CMP-01836

  • Laboratory instrument/analyser application software IVD
Medical grade Genius™ Review Station monitor for use with the Genius™ Digital Diagnostics System.
Hologic, Inc.
DISPLAY, 27IN, 8MP
In Commercial Distribution

  • 15420045514201 ()
CMP-01669

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045512535 ()
ASY-13755

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045512511 ()
CMP-01667

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045508163 ()
ASY-11145

  • Laboratory instrument/analyser application software IVD
The SecurView® DX diagnostic workstation Manager provides central database access and performs the image preparation for all connected SecurView DX Client workstations.
Hologic, Inc.
SVDX Manager
In Commercial Distribution

  • 15420045507388 ()
SVDX-00600-HIRES

  • Laboratory instrument/analyser application software IVD
The SecurView® RT technologist workstation Manager provides central database access and performs the image preparation for all connected SecurView RT Client workstations.
Hologic, Inc.
SVRT Manager
In Commercial Distribution

  • 15420045507371 ()
SVRT-00600R

  • Laboratory instrument/analyser application software IVD
The SecurView® RT technologist workstation is intended to be used by technologists to view images durign screening and diagnostic exams.
Hologic, Inc.
SVRT
In Commercial Distribution

  • 15420045507364 ()
SVRT-00300

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045507265 ()
ASY-10745

  • Laboratory instrument/analyser application software IVD
Kaluza C 10 User Network Educational License
Beckman Coulter, Inc.
10 User Network Educational License
In Commercial Distribution

  • 15099590705145 ()
C10580

  • Laboratory instrument/analyser application software IVD
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