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
Roche Diagnostics GmbH
08058113190
In Commercial Distribution

  • 07613336121443 ()
08058113190

  • Morphine/morphine metabolite IVD, reagent
No Description
Roche Diagnostics GmbH
08058008190
In Commercial Distribution

  • 07613336121405 ()
08058008190

  • Methadone IVD, reagent
No Description
Roche Diagnostics GmbH
08056927190
In Commercial Distribution

  • 07613336121054 ()
08056927190

  • Benzodiazepine group IVD, reagent
No Description
Roche Diagnostics GmbH
08056919190
In Commercial Distribution

  • 07613336170502 ()
08056919190

  • Benzodiazepine group IVD, reagent
No Description
Roche Diagnostics GmbH
08056889190
In Commercial Distribution

  • 07613336121030 ()
08056889190

  • Barbiturate IVD, reagent
No Description
Roche Diagnostics GmbH
08056781190
In Commercial Distribution

  • 07613336120996 ()
08056781190

  • Amphetamine/methamphetamine group IVD, reagent
No Description
REAL VIEW IMAGING LTD
HOLOSCOPE-i
In Commercial Distribution

  • 07290018862018 ()


  • Ultrasound imaging system workstation
  • CT system workstation
FILTER, DIASAFE PLUS
Fresenius Medical Care AG
5008201
In Commercial Distribution

  • 04039361001391 ()
  • 04039361001384 ()

  • Area/Surface Area: 2.2 Square meter
5008203

  • Haemodialysis system dialysate pyrogen filter
Diacap® Ultra Dialysis Fluid Filters
B.Braun Avitum AG
7107367
Not in Commercial Distribution

  • 04039239090496 ()
  • 04039239090489 ()
7107367

  • Haemodialysis system dialysate pyrogen filter
Planning Workstation (US)
KOH YOUNG TECHNOLOGY INC.
KY-PWS-0030-B
In Commercial Distribution

  • 08800050902666 ()


  • Stereotactic surgery system workstation
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