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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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Lumax™ - 60888937013445

Lumax™ Software Update pack
Coopersurgical, Inc.
53361
In Commercial Distribution

  • 60888937013445 ()


  • Urodynamic measurement system

Vue RIS - 60889978671366

RIS SOFTWARE < 25K EXAMS / YEAR
CARESTREAM HEALTH, INC.
Vue RIS
In Commercial Distribution

  • 60889978671366 ()
8671364

  • Radiology information system application software

Medoc Main Station Software - 07290103039011

Medoc Main Station Base Software
MEDOC LTD.
MMS
In Commercial Distribution

  • 07290103039011 ()
SW 00012

  • Thermotester, diagnostic

CareLink™ - 00763000424138

PRODUCT SOFTWARE MMT-7350 PROWEB 3.13A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000424138 ()


  • Patient health record information system application software

Kaluza C - 15099590705169

Kaluza C Flow Cytometry Software
Beckman Coulter, Inc.
Flow Cytometry Software
In Commercial Distribution

  • 15099590705169 ()
C21166

  • Laboratory instrument/analyser application software IVD

CareLink™ Clinic - 00763000984762

PRODUCT SOFTWARE MMT-7350 PROWEB 4.1A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000984762 ()


  • Patient health record information system application software

DYONICS - 00885554037616

DYONICS PULSE SOFTWARE TOP LEVEL
Smith & Nephew, Inc.
72204606
Not in Commercial Distribution

  • 00885554037616 ()
72204606

  • Multidisciplinary medical image management software

SafeRT-ID - 05056190500290

No Description
VISION RT LIMITED
Application Software
In Commercial Distribution

  • 05056190500290 ()


  • Patient-administration information system application software

SafeRT-ID - 05056190500283

No Description
VISION RT LIMITED
Server Software
In Commercial Distribution

  • 05056190500283 ()


  • Patient-administration information system application software

Virtual Field - 00860001720419

Virtual Field is a portable virtual reality visual field device. It runs a variety of visual field patterns, including but not limited to 10-2, 24-2, and 30-2, as well as multiple strategies, from suprathreshold screenings to full threshold tests. It also includes eye tracking capabilities, a color vision screening exam, and a pupillometer exam. The Virtual Field Website is used to launch exams, view patient results, and manage account information.
Field Virtual Inc
VF Software
In Commercial Distribution

  • 00860001720419 ()
Release Version 2023.4.2

  • Pupillometer, electrically-powered
  • Perimeter, automatic
  • Colour discrimination tester
  • Pupillograph
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