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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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IMAGE DIAGNOSTICS, INC - 00850977007430

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR,TELESCOPIC,ILEX W/IPS500A,120V,#A280-0600 OR W/IPS1000A #A280-0700
IMAGE DIAGNOSTICS, INC.
ilex55, 120V
In Commercial Distribution

  • 00850977007430 ()
A280-0600 OR A280-0700

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC. - 00850061871282

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 32IN. 4K MONITORS WITH RECORDER,ILEX DUO,120V,#A280-1569
IMAGE DIAGNOSTICS, INC.
ILEX DUO PLATINUM 32
In Commercial Distribution

  • 00850061871282 ()
A280-1569

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC. - 00850061871275

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 32IN. 4K MONITORS,ILEX DUO,120V,#A280-1568
IMAGE DIAGNOSTICS, INC.
ILEX DUO DIRECT PREMIUM 32
In Commercial Distribution

  • 00850061871275 ()
A280-1568

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC. - 00850061871268

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 27IN. 4K MONITORS,ILEX DUO,120V,#A280-1567
IMAGE DIAGNOSTICS, INC.
ILEX DUO DIRECT CONNECT 27
In Commercial Distribution

  • 00850061871268 ()
A280-1567

  • Diagnostic x-ray digital imaging system workstation

Widex - 05706069548587

Widex Link Connector
Widex A/S
WLC
In Commercial Distribution

  • 05706069548587 ()
8 924 0100 000

  • Hearing aid wireless-fitting computer-aided set

Widex - 05706069369755

Widex Tech module
Widex A/S
Tech module
In Commercial Distribution

  • 05706069369755 ()
8 915 0100 000

  • Hearing aid wireless-fitting computer-aided set

Widex - 05706069369168

Widex USB Link (Black )
Widex A/S
USBLink
In Commercial Distribution

  • 05706069369168 ()
8 917 0100 000

  • Hearing aid wireless-fitting computer-aided set

WAM (Work Area Management) - 00664369000752

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

  • 00664369000752 ()


  • Clinical laboratory 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
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