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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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Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Pro - 00849832009863

Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Pro
Leica Biosystems Richmond, Inc.
23DKI5807
Not in Commercial Distribution

  • 00849832009863 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive

Leica Biosystems CytoVision HD Image, Dell 5810 Basic, Win 7 Ultimate - 00849832009856

Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Ultimate
Leica Biosystems Richmond, Inc.
23DKI5800
Not in Commercial Distribution

  • 00849832009856 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive

Santastic Infrared Forehead Thermometer - 00860004330691

No Description
BUY SUPPLY INC
PG-IRT1602
In Commercial Distribution

  • 00860004330691 ()


  • Infrared patient thermometer, ear

Dynamyx Digital Pathology Software - 00860007120206

Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software. The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica’s Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips’ Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips’ Ultra Fast Scanner and Philips PP27QHD monitor.
OMNYX, LLC
2.4
In Commercial Distribution

  • 00860007120206 ()


  • Pathology information system application software

Remote Network Station - 00851725007245

No Audio Remote Network Station with Dell OptiPlex 7480 23.8" All-In-One Computer SW 02-18 unicast
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7480-U
In Commercial Distribution

  • 00851725007245 ()
RNS-6804-7480-U

  • Centralized patient monitor

Remote Network Station - 00851725007238

Remote Network Station with Dell OptiPlex 7480 23.8” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7480
In Commercial Distribution

  • 00851725007238 ()
RNS-6803-7480

  • 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 - 00851725007191

Remote Network Station with Dell OptiPlex 7470 23.8” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7470
In Commercial Distribution

  • 00851725007191 ()
RNS-6803-7470

  • Centralized patient monitor

Remote Network Station - 00851725007184

Remote Network Station with Dell OptiPlex 7460 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7460
In Commercial Distribution

  • 00851725007184 ()
RNS-6803-7460

  • Centralized patient monitor
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