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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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9tray Sorter - 04560189284005

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189284005 ()


  • Enzyme immunoassay (EIA) analyser IVD

AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 - 04560189283992

No Description
TOSOH CORPORATION
AIA-900
In Commercial Distribution

  • 04560189283992 ()


  • Enzyme immunoassay (EIA) analyser IVD

AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 - 04560189282896

No Description
TOSOH CORPORATION
AIA-360
In Commercial Distribution

  • 04560189282896 ()


  • Enzyme immunoassay (EIA) analyser IVD

Clinic Laptop - 00860003118382

No Description
Canary Medical USA LLC
43-5570-003-15
In Commercial Distribution

  • 00860003118382 ()


  • Patient health record information system

OR Laptop - 00860003118337

Dedicated Laptop PC, part of the OR Base Station System
Canary Medical USA LLC
43-5570-003-14
In Commercial Distribution

  • 00860003118337 ()


  • Patient health record information system

MEDTOXScan® Cleaning Cassette - 00690286000087

A cleaning cassette solely intended to clean the color Contact Imaging Sensor (CIS) in the MEDTOXScan® Reader.
MEDTOX DIAGNOSTICS, INC.
833076
In Commercial Distribution

  • 00690286000087 ()


  • Multiplex analyser IVD, laboratory

MEDTOXScan® QC Test Devices - 00690286000070

QC Test Devices used to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination. QC Test Devices are intended to function as an optical performance system check for the MEDTOXScan® Reader only, and not intended to replace the need for external controls.
MEDTOX DIAGNOSTICS, INC.
833075
In Commercial Distribution

  • 00690286000070 ()


  • Multiplex analyser IVD, laboratory

MEDTOXScan® Reader - 00690286000063

An instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Devices, which are one-step immunochromatographic tests for the rapid, qualitative detection of one or more drugs in human urine.
MEDTOX DIAGNOSTICS, INC.
833073
In Commercial Distribution

  • 00690286000063 ()


  • Multiplex analyser IVD, laboratory

WAM (Work Area Management) - 00664369000752

No Description
Sysmex America, Inc.
5.X
In Commercial Distribution

  • 00664369000752 ()


  • Clinical laboratory information system

StethoAI Digital Stethoscope - 00860011532804

A high-quality digital stethoscope that connects directly to the 3.5mm jack of your computer or your mobile phone.
Stethoai LLC
1
In Commercial Distribution

  • 00860011532804 ()
1

  • Electronic acoustic stethoscope
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