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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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Merit Medical Systems, Inc.
C
In Commercial Distribution

  • 10884450837549 ()
  • 00884450837542 ()
IN8VCF

  • Orthopaedic cement preparation/delivery kit
BD FACS™ Sample Prep Assistant III Software
Becton, Dickinson And Company
657765
In Commercial Distribution

  • 00382906577658 ()
657765

  • Laboratory instrument/analyser application software IVD
BD Synapsys™ Informatics Solution
BECTON, DICKINSON AND COMPANY
444139
In Commercial Distribution

  • 00382904441395 ()
444139

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystems Assay Disk SI Units version 22.0
ABBOTT LABORATORIES
04J6225
In Commercial Distribution

  • 00380740007584 ()
04J6225

  • Laboratory instrument/analyser application software IVD
CHECKLIST APP This app requires core.portal. The checklist app is a universal questionnaire and checklist system for collecting information during surgery. Checklists can be defined as customer-specific multilingual templates. The checklists are displayed in accordance with the language selected in the core.browser. The app generates a PDF report with the demographic patient data, information about the surgical intervention, a logo and the recorded data. The report is part of the documentation. The app does not spread the information collected.
Richard Wolf GmbH
5597706
Not in Commercial Distribution

  • 04055207070086 ()
5597706

  • Operating room audiovisual data/device management system application software
MEDIA ARCHIVE FILESHARE This module requires core.portal. It allows the storage of intraoperative data to an enabled directory in the hospital’s IT infrastructure. The module is required once for each file sharing approval.
Richard Wolf GmbH
5597203
Not in Commercial Distribution

  • 04055207070079 ()
5597203

  • Operating room audiovisual data/device management system application software
CORE.PORTAL SCHEDULING HL7 This module requires core.portal as a basis. It is used for transmitting demographic patient data or surgery scheduling data from a hospital information system via HL7 messages to core.portal. One module is required for each message type.
Richard Wolf GmbH
5597303
Not in Commercial Distribution

  • 04055207070062 ()
5597303

  • Operating room audiovisual data/device management system application software
CORE.PORTAL Establishes the connection between the intra-operative networks and the hospital-wide IT systems.Provides various services centrally in all operating rooms. Included are: Installation service Receiving and forwarding of patient lists by means of DICOM WORKLIST. Receiving and forwarding of images and videos by means of DICOM STORE. Intraoperative management of recorded images and videos using MEDIA ARCHIVE APP. A server, which provides the virtual environment with the ESXi operating system, is required for installation. The server hardware is not part of the Richard Wolf portfolio and must be provided by customers on their own.
Richard Wolf GmbH
5597101
In Commercial Distribution

  • 04055207058848 ()
5597101

  • Operating room audiovisual data/device management system application software
This media contains V 7.5 of the following registered Medical Devices: (DI)09120052070996 (SOFTWARE MAGELLAN V 7.X), (DI)09120052071009 (SOFTWARE MAGELLAN TRACKER V 7.X)
Tecan Austria GmbH
30231095 00
In Commercial Distribution

  • 09120052071504 ()
  • 09120052071511 ()
  • 09120052071528 ()
  • 09120052071535 ()
  • 09120052071542 ()
  • 09120052071559 ()
  • 09120052071566 ()
30231095

  • Laboratory instrument/analyser application software IVD
This media contains V 7.4 of the following registered Medical Devices: (DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X), (DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
Tecan Austria GmbH
30220141 00
In Commercial Distribution

  • 09120052071351 ()
  • 09120052071368 ()
  • 09120052071375 ()
  • 09120052071382 ()
  • 09120052071399 ()
  • 09120052071450 ()
  • 09120052071467 ()
30220141

  • Laboratory instrument/analyser application software IVD
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