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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No Audio Remote Network Station with Dell Inspiron 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-3464
In Commercial Distribution

  • 00851725007146 ()
RNS-6804-3464

  • Centralized patient monitor
Remote Network Station with Dell Inspiron 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-3464
In Commercial Distribution

  • 00851725007139 ()
RNS-6803-3464

  • Centralized patient monitor
No Description
BUY SUPPLY INC
PG-IRT1602
In Commercial Distribution

  • 00860004330691 ()


  • Infrared patient thermometer, ear
Speech Generating Device - Dell Venue Android - 10"
Lingraphicare America, Inc.
TouchTalk
In Commercial Distribution

  • 00850042278116 ()


  • Voice synthesizer/digitizer
Speech Generating Device - Dell Venue Windows - 10"
Lingraphicare America, Inc.
TouchTalk
In Commercial Distribution

  • 00850042278109 ()


  • Voice synthesizer/digitizer
KIT, C SECTION
Cardinal Health 200, LLC
PL23CSBUY
In Commercial Distribution

  • 50888439621462 ()
  • 10888439621464 ()
PL23CSBUY

  • Obstetrical/gynaecological surgical procedure kit, medicated
GENERAL LAPAROSCOPY PACK
Cardinal Health 200, LLC
SBA23CHBUY
In Commercial Distribution

  • 50888439679890 ()
  • 10888439679892 ()
SBA23CHBUY

  • Laparoscopic surgical procedure kit, non-medicated, single-use
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
Laptop Instructor DELL 7710 (Trade Show)
ZIRKONZAHN SRL
WRAB5161
In Commercial Distribution

  • D800WRAB5161 ()


  • Dental milling system, CAD/CAM, laboratory
No Audio Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6804-7460
Not in Commercial Distribution

  • 00841983104183 ()
RNS-6804-7460

  • Centralized patient monitor
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