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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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CEREC Guide - E27662374942

CEREC Guide Drill Key M Ø3.6
SIRONA Dental Systems GmbH
6237494
In Commercial Distribution

  • E27662374942 ()


  • CAD/CAM software

SIDEXIS XG - E27662291290

SIDEXIS XG Basis-DVD
SIRONA Dental Systems GmbH
6229129
Not in Commercial Distribution

  • E27662291290 ()


  • Radiological PACS software

Puritan Bennett - 10884521817609

NIV plus Software Upgrade Option US;For 980 Series Ventilator
Covidien LP
980NIVPLUS-US
In Commercial Distribution

  • 10884521817609 ()


  • Ventilator application software

Puritan Bennett - 10884521817593

IE Sync Trigger Upgrade Option US;For 980 Series Ventilator
Covidien LP
980IESYNC-US
In Commercial Distribution

  • 10884521817593 ()


  • Ventilator application software

Puritan Bennett - 10884521817586

High Flow O2 Therapy Upgrade Option US;For 980 Series Ventilator
Covidien LP
980HFO2T-US
In Commercial Distribution

  • 10884521817586 ()


  • Ventilator application software

radiance - 08436567540017

Radiance V4 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Radiance V4 shall be clinically qualified radiation therapy staff trained in using the system.
GMV SOLUCIONES GLOBALES INTERNET SA
4
In Commercial Distribution

  • 08436567540017 ()


  • Radiation therapy software

radiance - 08436567540000

Radiance V3 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Radiance V3 shall be clinically qualified radiation therapy staff trained in using the system.
GMV SOLUCIONES GLOBALES INTERNET SA
3
In Commercial Distribution

  • 08436567540000 ()


  • Radiation therapy software

ANAEYES OCT for system linkage - 03615020000496

No Description
ESSILOR INTERNATIONAL
ANAEYES OCT
In Commercial Distribution

  • 03615020000496 ()


  • Camera application software

AVEA - 10846446017564

AVEA NIMV+VG SW KEY
Carefusion Corporation
63865
Not in Commercial Distribution

  • 10846446017564 ()


  • Ventilator application software

ResScan - 08401934313396

ResScan V7.0.2
RESMED CORP.
31339
In Commercial Distribution

  • 08401934313396 ()


  • Ventilator application software
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