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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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BruxZir® NOW SRC for Inclusive® Tapered Implant System Ø 3.7/4.2 mm, A3
Prismatik Dentalcraft, Inc
70-1185-NOW0098
In Commercial Distribution

  • D745701185NOW00980 ()
70-1185-NOW0098

  • Dental implant suprastructure, permanent, preformed
Primescan AC with touch pad, steel window sleeve, Special Edition for SDC (Smile Direct Club)
SIRONA Dental Systems GmbH
6729615
In Commercial Distribution

  • E27667296150 ()


  • Dental milling system, CAD/CAM, chairside
Omnicam AC B-Ware (refurbished)
SIRONA Dental Systems GmbH
6718857
In Commercial Distribution

  • E27667188570 ()


  • Dental milling system, CAD/CAM, chairside
Omnicam AC with touch pad, steel mirror sleeve, only for USA
SIRONA Dental Systems GmbH
6692730
In Commercial Distribution

  • E27666927300 ()


  • Dental milling system, CAD/CAM, chairside
Primescan AC with touch pad, steel window sleeve, only for USA
SIRONA Dental Systems GmbH
6692714
In Commercial Distribution

  • E27666927140 ()


  • Dental milling system, CAD/CAM, chairside
Grid 3D Image Distortion Analysis System- Includes One Phantom and 2 software licenses..
Modus Medical Devices Inc
100-1017
In Commercial Distribution

  • G34310010170 ()


  • Multi-modality therapeutic radiation phantom, test object
No Description
LOCALITE GmbH
Functional Data (Software Module)
In Commercial Distribution

10233

  • Stereotactic neuronavigation/planning system
No Description
LOCALITE GmbH
Functional Data (Software Module)
Not in Commercial Distribution

  • G076A010233AM3N30 ()
10233

  • Stereotactic neuronavigation/planning system
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
UniSoft software, Edition 2000
In Commercial Distribution

  • EPTWS1000090 ()
S100009

  • Multi-modality therapeutic radiation phantom, anthropomorphic
Web application
MC10, INC.
SW-0028
Not in Commercial Distribution

  • B493SW0028 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
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