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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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OmniLab Direct Software
Respironics, Inc.
OmniLab Direct Software - 2
In Commercial Distribution

  • 00606959044302 ()
1112033

  • Clinical laboratory information system
OmniLab Direct Software, Web
Respironics, Inc.
OmniLab Direct, Web Software - 2
In Commercial Distribution

  • 00606959044296 ()
1113127

  • Clinical laboratory information system
OmniLab Connect System, Brazil
Respironics, Inc.
OmniLab Connect System, BR
Not in Commercial Distribution

  • 00606959043466 ()
BR1111076

  • Clinical laboratory information system
DreamStation Nonin SpO2 Cable
Respironics, Inc.
DreamStation Nonin SpO2 Cable
In Commercial Distribution

  • 00606959040465 ()
1121694

  • Clinical laboratory information system
PRI Cellular Modem, Australia, Canada
Respironics, Inc.
PRI Cellular Modem, AU, CA
In Commercial Distribution

  • 00606959040403 ()
100215C

  • 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
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
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
Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation
Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation
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