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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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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
The IntelliSpace Portal IX V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal IX V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.
Philips Medical Systems Nederland B.V.
6.5
Not in Commercial Distribution

  • 00884838083653 ()


  • CT system workstation
The IntelliSpace Portal V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.
Philips Medical Systems Nederland B.V.
6.5
Not in Commercial Distribution

  • 00884838083646 ()


  • CT system workstation
SensaVue Cart Assembly
Philips DS North America LLC
4535-303-46291
Not in Commercial Distribution

  • 00884838081758 ()
453530346291

  • MRI system workstation
Kit Includes: R067 Columbia 4L-4R R138R Montana Jack® Rigid R120 Montana 4-5™ Scaler R030R Amazing Gracey™ 15-16 Rigid T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7 R028R Amazing Gracey™ 13-14 Rigid
PDT, INC.
R978 Gross Debridement Kit
In Commercial Distribution

  • 00813677024510 ()
R978

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
SCALER, DOUBLE END, TRADE IN, OFFSET SICKLE MONTANA JACK UNIVERSAL R138 THIN BLADE, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCNMJF
In Commercial Distribution

  • 00840018647466 ()


  • Manual dental scaler, reusable
No Description
W.H. Holden, Inc.
70-5164RK
In Commercial Distribution

  • D928705164RK0 ()


  • Periodontal curette
No Description
PDT, INC.
Montana 4-5 Scaler
In Commercial Distribution

  • 00813677020826 ()
R120

  • Manual dental scaler, reusable
No Description
Roche Diagnostics GmbH
06779344190
In Commercial Distribution

  • 04015630934447 ()
06779344190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
06779336190
In Commercial Distribution

  • 04015630934416 ()
06779336190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08764778190
In Commercial Distribution

  • 07613336164891 ()
08764778190

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent
No Description
Roche Diagnostics GmbH
08445605190
In Commercial Distribution

  • 07613336157800 ()
08445605190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08058849190
Not in Commercial Distribution

  • 07613336121627 ()
08058849190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08057435190
In Commercial Distribution

  • 07613336121108 ()
08057435190

  • Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08056684190
In Commercial Distribution

  • 07613336120934 ()
08056684190

  • Acetaminophen IVD, kit, spectrophotometry
Automatic contouring for radiation treatment planning.
Quantitative Radiology Solutions LLC
QCCv1.0.0
Not in Commercial Distribution

  • 00860006956004 ()


  • Radiation therapy treatment planning workstation
110~240V~ 120kV
DRGEM Corporation
JADE-40
In Commercial Distribution

  • 08800011150099 ()


  • Mobile basic diagnostic x-ray system, analogue
100~240V~ 120kV
DRGEM Corporation
JADE-32
In Commercial Distribution

  • 08800011150082 ()


  • Mobile basic diagnostic x-ray system, analogue
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
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

  • 08436046003286 ()
CB40

  • Mobile basic diagnostic x-ray system, analogue
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