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
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroFortis Neuro Omega Drive Headstage KIT
In Commercial Distribution

  • 27290114062439 ()
750-020070-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with NeuroFortis Drive Headstage
In Commercial Distribution

  • 27290114062422 ()
NOW-020070-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EMG- recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450938 ()
750-02J013-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG- Recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450891 ()
750-02J016-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG Recording Kit
In Commercial Distribution

  • 27290016450877 ()
750-02A016-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EEG Recording Kit
In Commercial Distribution

  • 27290016450853 ()
750-02A011-00

  • Depth electrode
Includes TX Nozzle, preliminary filter, 8" hose section assembly, connects to Hose, Intended for short procedures of up to 15 minutes duration
ACUDERM, INC.
TXPACK
In Commercial Distribution

  • 10814105020491 ()


  • Surgical plume evacuation system
Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or laparoscopic use. 110vac motor
ACUDERM, INC.
EVAC II-1
In Commercial Distribution

  • 10814105020453 ()


  • Surgical plume evacuation system
All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other laser or electrosurgical units in open procedures. 220vac motor
ACUDERM, INC.
EVAC IE-2
In Commercial Distribution

  • 10814105020446 ()


  • Surgical plume evacuation system
All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other laser or electrosurgical units in open procedures. 110vac motor
ACUDERM, INC.
EVAC IE-1
In Commercial Distribution

  • 10814105020439 ()


  • Surgical plume evacuation system
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