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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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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 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

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

Accuray Precision® Treatment Planning System - 00811376030221

Accuray Precision® Treatment Planning System
Accuray Incorporated
1049210-000
In Commercial Distribution

  • 00811376030221 ()
NA

  • Radiation therapy treatment planning workstation

Accuray Precision Treatment Planning System - 00811376030146

Accuray Precision™ Treatment Planning System (Version 3.1)
Accuray Incorporated
1070891
In Commercial Distribution

  • 00811376030146 ()
NA

  • Radiation therapy treatment planning workstation

Accuray Precision Treatment Planning System - 00811376030092

Accuray Precision™ Treatment Planning System (Version 3.0)
Accuray Incorporated
1063143
In Commercial Distribution

  • 00811376030092 ()
NA

  • Radiation therapy treatment planning workstation

DRGEM - 08800011150099

110~240V~ 120kV
DRGEM Corporation
JADE-40
In Commercial Distribution

  • 08800011150099 ()


  • Mobile basic diagnostic x-ray system, analogue

DRGEM - 08800011150082

100~240V~ 120kV
DRGEM Corporation
JADE-32
In Commercial Distribution

  • 08800011150082 ()


  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003293

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003293 ()
CB50

  • Mobile basic diagnostic x-ray system, analogue
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