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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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mymobility® Platform - 00887868581168

No Description
Zimmer Us, Inc.
MMIOS001
In Commercial Distribution

  • 00887868581168 ()
MMIOS001

  • Biomechanical function analysis/rehabilitation software

mymobility® Platform - 00887868581151

No Description
Zimmer Us, Inc.
MMCWE001
In Commercial Distribution

  • 00887868581151 ()
MMCWE001

  • Biomechanical function analysis/rehabilitation software

RapidCheck - B136RC10000

The RapidCHECK platform is intended for supporting users in analyzing diagnostic imaging data to ensure the performance of the diagnostic system is operating within safe and expected tolerances.
SUN NUCLEAR CORP.
RC1000
In Commercial Distribution

  • B136RC10000 ()


  • Multidisciplinary medical image management software

Sunquest VUE - B236VUE3000

Sunquest VUE supports laboratories in the management of patient reports and to transfer, store, and display test results and information.
CliniSys, Inc
3.0
Not in Commercial Distribution

  • B236VUE3000 ()


  • Pathology information system application software

Sunquest VUE - B236VUE202210

The intended use of Sunquest VUE is to support laboratories in the management of patient reports and to transfer, store, and display test results and information.
CliniSys, Inc
2022.1
In Commercial Distribution

  • B236VUE202210 ()


  • Pathology information system application software

Sunquest PowerPath - B236PWP13000

The intended use of Sunquest PowerPath is to support anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information.
CliniSys, Inc
13.0
In Commercial Distribution

  • B236PWP13000 ()


  • Pathology information system application software

Sunquest PowerPath - B236PWP12000

Sunquest PowerPath supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information.
CliniSys, Inc
12.0
Not in Commercial Distribution

  • B236PWP12000 ()


  • Pathology information system application software

Sunquest CoPathPlus - B236CPP8000

Sunquest CoPathPlus supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information..
CliniSys, Inc
8.0
In Commercial Distribution

  • B236CPP8000 ()


  • Pathology information system application software

Sunquest CoPathPlus - B236CPP7100

Sunquest CoPathPlus supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information..
CliniSys, Inc
7.1
Not in Commercial Distribution

  • B236CPP7100 ()


  • Pathology information system application software

EVOYA Platform - 06438147366804

The Evoya Software Platform is an in vitro diagnostics modular software intended to be used together with Neonatal screening assay systems to enable workflow activities, data management, results analysis and reporting. The EVOYA Software Platform is intended to be used by trained laboratory professionals. The Evoya Software Platform is intended for in vitro diagnostic use.
Wallac Oy
5021-1000
In Commercial Distribution

  • 06438147366804 ()
5021-1000

  • Clinical laboratory information system
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