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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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IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 32IN. MONITOR,FIXED,MONITOR CART,IDI W/4K MONITOR,#A280-0821
IMAGE DIAGNOSTICS, INC.
MONITOR CART,IDI W/4K MONITOR
In Commercial Distribution

  • 00850977007720 ()
A280-0821

  • Diagnostic x-ray digital imaging system workstation
IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 32IN. MONITOR,FIXED,MONITOR CART,IDI W/HD MONITOR,#A280-0630
IMAGE DIAGNOSTICS, INC.
MONITOR CART,IDI W/HD MONITOR
In Commercial Distribution

  • 00850977007713 ()
A280-0630

  • Diagnostic x-ray digital imaging system workstation
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
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
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
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
No Description
Canary Medical USA LLC
43-5570-003-15
In Commercial Distribution

  • 00860003118382 ()


  • Patient health record information system
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
No Description
Sysmex America, Inc.
5.X
In Commercial Distribution

  • 00664369000752 ()


  • Clinical laboratory information system
Widex Tech module
Widex A/S
Tech module
In Commercial Distribution

  • 05706069369755 ()
8 915 0100 000

  • Hearing aid wireless-fitting computer-aided set
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