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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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eNcounter - 00850033167115

A complete telehealth platform that offers secure telemedicine software solutions with diagnostic and clinical workflow capabilities combined with interoperable services that work with an existing platform including scheduling, video consultations, data integration, and integration management services.
Globalmed Holdings, LLC
eNcounter
In Commercial Distribution

  • 00850033167115 ()


  • Patient health record information system

OR Barcode Scanner - 00850015699016

After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components.
Canary Medical USA LLC
43-5570-006-14
In Commercial Distribution

  • 00850015699016 ()


  • Patient health record information system

WAM (Work Area Management) - 00664369000752

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

  • 00664369000752 ()


  • Clinical laboratory information system

Quantum ® - 05060434420039

Quantum Data Management Unit
SPECTRUM MEDICAL LIMITED
QDMU
Not in Commercial Distribution

  • 05060434420039 ()
3008-001-010

  • Patient health record information system

System M ® - 05060434420015

Data Management Monitor
SPECTRUM MEDICAL LIMITED
VIPER DM
Not in Commercial Distribution

  • 05060434420015 ()
3005-001-200

  • Patient health record information system

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

DelWorks - 00858340006097

PORTABLE WORKSTATION Wirelessly Transfer Images Directly to PACS, Ultra-light, and Portable, Design tested to handle, water, dust, and splash resistance The DELWORKS FIT portable tablet workstation aims to maximize the portability and efficiency of the DELWORKS software - utilizing it anytime, anywhere.
Del Medical, Inc.
3.0
In Commercial Distribution

  • 00858340006097 ()


  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC. - 00850977007928

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 27IN. 4K MONITORS,PREVIEW DISPLAY,MDS,120V,#A280-0983
IMAGE DIAGNOSTICS, INC.
MDS, 4K, 120V
In Commercial Distribution

  • 00850977007928 ()
A280-0983

  • Diagnostic x-ray digital imaging system workstation
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