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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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ILUMIEN™ - 00812059020560

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1.1 Software
In Commercial Distribution

  • 00812059020560 ()
100111860

  • Coronary optical coherence tomography system

UbiqVue - B353UA2550S1

Central Server Software
Lifesignals, Inc.
UA2550-S
In Commercial Distribution

  • B353UA2550S1 ()


  • Network server

UbiqVue - B353UA2550RB1

Relay Bridge Software
Lifesignals, Inc.
UA2550-RB
In Commercial Distribution

  • B353UA2550RB1 ()


  • Physiological measuring device wireless data capture/transfer unit

UbiqVue - B353UA2550BG1

Bluetooth Gateway Software
Lifesignals, Inc.
UA2550-BG
In Commercial Distribution

  • B353UA2550BG1 ()


  • Physiological measuring device wireless data capture/transfer unit

Polaroid DDS - 10667147001542

Polaroid DDS software
Synca Marketing Inc
V8
In Commercial Distribution

  • 10667147001542 ()
PDDS

  • Radiology information system application software

XDR - D787XDRSW300

Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW300 ()
XDRSW30

  • General-purpose dental x-ray system application software

XDR - D787XDRSW1

Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW1 ()
XDRSW

  • General-purpose dental x-ray system application software

RMS - 08031527021188

Remote Monitoring Software
MICROPORT CRM SRL
RMS
In Commercial Distribution

  • 08031527021188 ()
RMS

  • Cardiology information system application software

DCTclock - B626100410

DCTclock Uploader Software
Linus Health, Inc.
10041
In Commercial Distribution

  • B626100410 ()
10041

  • Drawing-test cognitive function analysis device

Arthrex® - 00888867100626

Synergy.net Management Software
ARTHREX, INC.
AR-3200-1030
In Commercial Distribution

  • 00888867100626 ()
AR-3200-1030

  • Operating room audiovisual data/device management system
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