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.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114064525 ()
NOW-020021-00

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

  • 27290114063856 ()
NOW-020021-00

  • Depth electrode
DELTA-9-THC 8 NG/ML
UTAK LABORATORIES, INC.
DELTA 9 OMEGA
In Commercial Distribution

  • B800DELTA9THC8NGML5 ()
  • B800DELTA9THC8NGML0 ()

  • Total Volume: 1 Milliliter
DELTA 9 OMEGA

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
UTAK LABORATORIES, INC.
DELTA 9 OMEGA
In Commercial Distribution

  • B800DELTA9OMEGA5 ()
  • B800DELTA9OMEGA0 ()

  • Total Volume: 1 Milliliter
DELTA 9 OMEGA

  • Multiple-type clinical chemistry analyte profile IVD, control
3M™ Unitek™ Prestige Series Omega Loop Forming Pliers Replacement Tip, 900-708, 1/Ea
3M UNITEK CORPORATION
900-709
In Commercial Distribution

  • 00652221111005 ()
900-709

  • Orthodontic pliers
Digital Medical Image Processor
OMEGA MEDICAL IMAGING, LLC
IPS-100
In Commercial Distribution

  • 00853901007032 ()


  • X-ray system computer, diagnostic, general-purpose
Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ray Tube, Flat Panel Detector and Image Processor.
OMEGA MEDICAL IMAGING, LLC
Soteria.AI
In Commercial Distribution

  • 00853901007025 ()


  • Stationary angiographic x-ray system, digital
CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consisting of a patient table, C-arm positioner, X-ray tube, X-ray generator, Flat Panel Detector and Image Processor. The system is configurable with selectable components i.e. tubes, generators, tables, c-arms and flat panel detectors per customer requirements.
OMEGA MEDICAL IMAGING, LLC
CS-series-FP
In Commercial Distribution

  • 00853901007018 ()


  • Stationary angiographic x-ray system, digital
30.0 MM X 5.8 MM X 0.61 MM SAGITTAL BLADE
Omega Surgical Instruments Inc
ZMS-3058
In Commercial Distribution

  • 00817438028601 ()


  • Surgical saw blade, sagittal, single-use
30.0 MM X 5.8 MM X 0.61 MM SAGITTAL BLADE
Omega Surgical Instruments Inc
SM-3058
In Commercial Distribution

  • 00817438028595 ()


  • Surgical saw blade, sagittal, single-use
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