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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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TruSPECT - 07290108670233

TruSPECT Radiological Image Processing Station
SPECTRUM DYNAMICS MEDICAL, INC
STANDALONE PROCESSING STATION
In Commercial Distribution

  • 07290108670233 ()
8010290-01

  • SPECT system workstation

D-SPECT ® processing and Reviewing Workstation - 07290108670080

Single Photon Emission Computed Tomography system, stand alone processing station.
SPECTRUM DYNAMICS MEDICAL, INC
Stand Alone
Not in Commercial Distribution

  • 07290108670080 ()
8010113-01

  • SPECT system workstation

ONLINE TDM Vancomyin Gen.3 - 04015630934447

No Description
Roche Diagnostics GmbH
06779344190
In Commercial Distribution

  • 04015630934447 ()
06779344190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Vancomyin Gen.3 - 04015630934416

No Description
Roche Diagnostics GmbH
06779336190
In Commercial Distribution

  • 04015630934416 ()
06779336190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE DAT Lysergic Acid Diethylamide - 07613336164891

No Description
Roche Diagnostics GmbH
08764778190
In Commercial Distribution

  • 07613336164891 ()
08764778190

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent

ONLINE TDM Vancomycin Gen.3 - 07613336157800

No Description
Roche Diagnostics GmbH
08445605190
In Commercial Distribution

  • 07613336157800 ()
08445605190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Vancomycin Gen.3 - 07613336121627

No Description
Roche Diagnostics GmbH
08058849190
Not in Commercial Distribution

  • 07613336121627 ()
08058849190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Carbamazepine Gen.4 - 07613336121108

No Description
Roche Diagnostics GmbH
08057435190
In Commercial Distribution

  • 07613336121108 ()
08057435190

  • Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Acetaminophen Gen.2 - 07613336120934

No Description
Roche Diagnostics GmbH
08056684190
In Commercial Distribution

  • 07613336120934 ()
08056684190

  • Acetaminophen IVD, kit, spectrophotometry

Quantaras Contour Companion - 00860006956004

Automatic contouring for radiation treatment planning.
Quantitative Radiology Solutions LLC
QCCv1.0.0
Not in Commercial Distribution

  • 00860006956004 ()


  • Radiation therapy treatment planning workstation
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