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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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Remote Network Station - 00851725007283

No Audio Remote Network Station with Dell OptiPlex 7490 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7490
In Commercial Distribution

  • 00851725007283 ()
RNS-6804-7490

  • Centralized patient monitor

Remote Network Station - 00851725007221

No Audio Remote Network Station with Dell OptiPlex 7480 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7480
In Commercial Distribution

  • 00851725007221 ()
RNS-6804-7480

  • Centralized patient monitor

Remote Network Station - 00851725007207

No Audio Remote Network Station with Dell OptiPlex 7470 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7470
In Commercial Distribution

  • 00851725007207 ()
RNS-6804-7470

  • Centralized patient monitor

Remote Network Station - 00851725007177

No Audio Remote Network Station with Dell OptiPlex 7460 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7460
In Commercial Distribution

  • 00851725007177 ()
RNS-6804-7460

  • Centralized patient monitor

BRAEBON MediByte - B14088900

Cable to connect MediByte to a computer for configuration and data upload.
Braebon Medical Corporation
8890
In Commercial Distribution

  • B14088900 ()
8890

  • Electrical-only medical device connection cable, reusable

QVCAD System - B630QVCS346

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS344

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software

ThinPrep Imaging System - 15420045504042

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045504042 ()
ASY-08388

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045501041

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045501041 ()
ASY-06030

  • Laboratory instrument/analyser application software IVD

Thinprep Imaging System - 15420045508163

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045508163 ()
ASY-11145

  • Laboratory instrument/analyser application software IVD
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