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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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No Description
MONOBIND, INC.
IN008
In Commercial Distribution

  • 00816870020013 ()
IN008

  • Chemiluminescent immunoassay analyser IVD
No Description
MONOBIND, INC.
IN010
In Commercial Distribution

  • 00816870020006 ()
IN010

  • Chemiluminescent immunoassay analyser IVD
Wireless Imaging System
FORESEESON CUSTOM DISPLAYS, INC.
WIS4000
In Commercial Distribution

  • 00810000890040 ()
WIS4000

  • Portable computer
No Description
Maquet Critical Care AB
6881603
In Commercial Distribution

  • 07325710001806 ()


  • Anaesthesia information system
The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The system is for in vitro diagnostic use only. The chemistry module of the DxC 500i Clinical Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. The immunoassay module of the DxC 500i Clinical Analyzer is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Beckman Coulter, Inc.
C13252
In Commercial Distribution

  • 15099590742331 ()


  • Chemiluminescent immunoassay analyser IVD
The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Beckman Coulter, Inc.
C11137
In Commercial Distribution

  • 15099590732103 ()
C11137

  • Chemiluminescent immunoassay analyser IVD
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
23020006
In Commercial Distribution

  • 06947145582746 ()
23020006

  • Chemiluminescent immunoassay analyser IVD
LCD touch screen recording system with HDMI loop through. Software version 1.7.28
Nds Surgical Imaging LLC
Evo4K130
Not in Commercial Distribution

  • 00817613021137 ()


  • Endoscopic video image processing unit
LCD touch screen recording system with HDMI loop through. Software version 1.7.25
Nds Surgical Imaging LLC
Evo4K130
In Commercial Distribution

  • 00817613021090 ()


  • Endoscopic video image processing unit
DICOM Media Creator - USB Thermal
Storage Solutions Technology Group Inc.
DMC-EZ USB
In Commercial Distribution

  • 00850018049139 ()
DMC-EZ USB

  • DICOM image data disc-recording unit
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