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

  • 27290114063856 ()
NOW-020021-00

  • Depth electrode
ERBE NESSY® Omega Plate USA (85+23)cm² , with cable 3 m
Erbe Elektromedizin GmbH
20193-084
In Commercial Distribution

  • 04050147015593 ()
  • 04050147005235 ()
  • 04050147017481 ()

  • Area/Surface Area: 85.000 Square centimeter
20193-084

  • Electrosurgical return electrode, single-use
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
2.0 MM X 65.0 MM X 12.0 MM STRAIGHT SHANNON BUR, 3 FLUTE
Omega Surgical Instruments Inc
SH206512
In Commercial Distribution

  • 00817438028533 ()


  • Orthopaedic bur, single-use
2.0 MM X 65.0 MM X 8.0 MM STRAIGHT SHANNON BUR, 3 HELICAL FLUTE
Omega Surgical Instruments Inc
SH206508
In Commercial Distribution

  • 00817438028526 ()


  • Orthopaedic bur, single-use
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