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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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VMA Motion Normalizer (Console, Table, and Upright assemblies)
ORTHO KINEMATICS, INC.
3
In Commercial Distribution

  • 00868579000247 ()


  • Diagnostic x-ray digital imaging system workstation
No Description
ORTHO KINEMATICS, INC.
2
In Commercial Distribution

  • 00868579000209 ()


  • Diagnostic x-ray digital imaging system workstation
FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.
FUJIFILM CORPORATION
CR-VW674
In Commercial Distribution

  • 04547410316926 ()


  • Diagnostic x-ray digital imaging system workstation
Sentosa ST401i is used for emulsion PCR and forms part of SQ301 Platform.
VELA OPERATIONS SINGAPORE PTE. LTD.
400124
In Commercial Distribution

  • 08885013950069 ()
400124

  • Clinical laboratory information system
ST401e is used for enrichment and forms part of SQ301 Platform.
VELA OPERATIONS SINGAPORE PTE. LTD.
400120
In Commercial Distribution

  • 08885013950076 ()
400120

  • Clinical laboratory information system
The Sentosa® SQ301 Platform is an in vitro diagnostic system composed of a sequencing instrument that measures the hydrogen ions that are generated during the incorporation of nucleotides in the DNA sequencing reaction and the ancillary instrumentation necessary for sample processing. This platform is used in conjunction with instrument-specific library preparation kits, template kits, sequencing kits, chip kits and data analysis software. The Sentosa® SQ301 Platform is intended for targeted sequencing of various biological samples. The Sentosa® SQ301 Platform is not intended for whole genome or de novo sequencing.
VELA OPERATIONS SINGAPORE PTE. LTD.
7468
In Commercial Distribution

  • 08885013950045 ()
400103

  • Clinical laboratory information system
Trilogy Ventilator Car DC Power Cable
Respironics, Inc.
00
In Commercial Distribution

  • 00606959043268 ()
1067424

  • Clinical laboratory information system
RJ9 to 2.5mm 3" Female Adapter Cable
Respironics, Inc.
RJ9 to 2.5mm 3" Female Adapter Cable
In Commercial Distribution

  • 00606959043244 ()
1080250

  • Clinical laboratory information system
RJ9 Nurse Call Cable - Open End
Respironics, Inc.
RJ9 Nurse Call Cable - Open End
In Commercial Distribution

  • 00606959043190 ()
1080249

  • Clinical laboratory information system
RJ9 to 1/4" Nurse Call Cable Alarm - Open
Respironics, Inc.
RJ9 to 1/4" Nurse Call Cable Alarm - Open
In Commercial Distribution

  • 00606959043183 ()
1080248

  • Clinical laboratory information system
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