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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3M™ Unitek™ Prestige Omega Loop Forming Pliers, 900-707, 1/Ea
3M UNITEK CORPORATION
900-708
In Commercial Distribution

  • 00652221110992 ()
900-708

  • Orthodontic pliers
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega HS
In Commercial Distribution

  • 07290014954922 ()
750-000070-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega HS
In Commercial Distribution

  • 07290014954915 ()
750-000020-00

  • Neurological stereotactic surgery system
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-172-720
In Commercial Distribution

  • 09348215076566 ()


  • Orthopaedic implant driver
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755198399 ()
C-008.33.601

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
DV1 CAMERA
In Commercial Distribution

  • 04053755181711 ()
C-008.33.563

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755153695 ()
C-008.33.502

  • Indirect binocular ophthalmoscope
CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4.
OMEGA MEDICAL IMAGING, LLC
CS50
In Commercial Distribution

  • 00853901007001 ()


  • Stationary angiographic x-ray system, digital
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega system
In Commercial Distribution

  • 07290114061506 ()
NOM-000000-00

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

  • 27290114064525 ()
NOW-020021-00

  • Depth electrode
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