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 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
20.0 MM X 7.0 MM X 0.56 MM SAGITTAL BLADE
Omega Surgical Instruments Inc
ZMS-2007
In Commercial Distribution

  • 00817438028519 ()


  • Surgical saw blade, sagittal, single-use
4.0 MM X 2.35 MM X 65.0 MM OVAL STAINLESS STEEL BUR W/O-NOTCH, 10 FLUTE
Omega Surgical Instruments Inc
O40-65-01NS
In Commercial Distribution

  • 00817438028496 ()


  • Orthopaedic bur, single-use
1.1 MM SIDE CUTTING HIGH SPEED ROUTER SS BUR, 8CM, RED
Omega Surgical Instruments Inc
MR8TA11
In Commercial Distribution

  • 00817438028465 ()


  • Orthopaedic bur, single-use
50.5 MM X 1.21 MM RECIPROCATING BLADE
Omega Surgical Instruments Inc
ZH-400
In Commercial Distribution

  • 00817438028434 ()


  • Surgical saw blade, reciprocating, single-use
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