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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
Roche Diagnostics GmbH
4642481190
Not in Commercial Distribution

  • 04015630997978 ()
4642481190

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
6769942190
In Commercial Distribution

  • 04015630935031 ()
6769942190

  • Acetaminophen IVD, kit, spectrophotometry
No Description
Roche Diagnostics GmbH
4642490190
Not in Commercial Distribution

  • 04015630997961 ()
4642490190

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
4642503190
Not in Commercial Distribution

  • 04015630997930 ()
4642503190

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08056919190
In Commercial Distribution

  • 07613336170502 ()
08056919190

  • Benzodiazepine group IVD, reagent
No Description
Roche Diagnostics GmbH
08771669190
Not in Commercial Distribution

  • 07613336166239 ()
08771669190

  • Cannabinoid/cannabinoid metabolite IVD, reagent
No Description
Roche Diagnostics GmbH
08058644190
In Commercial Distribution

  • 07613336121511 ()
08058644190

  • Cannabinoid/cannabinoid metabolite IVD, reagent
No Description
Roche Diagnostics GmbH
08058113190
In Commercial Distribution

  • 07613336121443 ()
08058113190

  • Morphine/morphine metabolite IVD, reagent
No Description
Roche Diagnostics GmbH
08056781190
In Commercial Distribution

  • 07613336120996 ()
08056781190

  • Amphetamine/methamphetamine group IVD, reagent
No Description
Roche Diagnostics GmbH
08058130190
In Commercial Distribution

  • 07613336121450 ()
08058130190

  • Phencyclidine (PCP) 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
08056889190
In Commercial Distribution

  • 07613336121030 ()
08056889190

  • Barbiturate IVD, reagent
Assort. discovery® pearl,McLaugh.18,15-45 / Brackets / For further information please visit our online-
DENTAURUM GmbH & Co.KG
718-702-85
In Commercial Distribution

  • J011728702850 ()


  • Orthodontic bracket, ceramic
No Description
REAL VIEW IMAGING LTD
HOLOSCOPE-i
In Commercial Distribution

  • 07290018862018 ()


  • Ultrasound imaging system workstation
  • CT system workstation
PLNG STATION 9734048R STEALTHSTATION S7
MEDTRONIC NAVIGATION, INC.
9734048R
In Commercial Distribution

  • 00643169777316 ()


  • Stereotactic surgery system workstation
The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-20HP3E
In Commercial Distribution

  • 10868277000454 ()
  • 00868277000457 ()
  • 20868277000451 ()


  • Haemodialysis system dialysate pyrogen filter
The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-10HP3E
In Commercial Distribution

  • 10868277000447 ()
  • 00868277000440 ()
  • 20868277000444 ()


  • Haemodialysis system dialysate pyrogen filter
DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter
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
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