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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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and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
10 Fr
In Commercial Distribution

  • 10860000931349 ()
  • 00860000931342 ()

  • 10 Fr (3.7mm)X 49”(100cm)
  • Catheter Gauge: 10 French
GFTB 510

  • Nasogastric feeding tube
and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
8 Fr
In Commercial Distribution

  • 10860000931332 ()
  • 00860000931335 ()

  • Catheter Gauge: 8 French
  • 8 FR (3.3mm)X 32”(80cm)
GFTB 508

  • Nasogastric feeding tube
Tracheostomy Care Tray with Gloves, Sterile
Dynarex Corporation
14001
In Commercial Distribution

  • 00860008059567 ()
  • 00860008123244 ()


  • Tracheostomy tube neck holder, reusable
No Description
Avive Solutions, Inc.
AED01
In Commercial Distribution

  • 00860002508559 ()


  • Rechargeable public automated external defibrillator
microTargeting Controller with motor option for use with STar and mT Drives
FHC, INC.
FC1008-00826
In Commercial Distribution

  • 00873263008263 ()
FC1008

  • Neurosurgical micro targeting drive
Obstructive Sleep Apnea with Iterative Adjustment and Patient Monitoring
PROSOMNUS SLEEP TECHNOLOGIES
IA Monogram Monitor
In Commercial Distribution

  • 00863039000430 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
ZipCombo Centrifuge, hematocrit rotor, capacity 12-40mm tubes
LW SCIENTIFIC, INC.
ZCC-12HD-40T3
In Commercial Distribution

  • 00664816001745 ()


  • Microhaematocrit centrifuge IVD
DenteShield Sample Opaque with Fluoride
ELEVATE ORAL CARE, LLC
685DSSAMP
Not in Commercial Distribution

  • 00858290006598 ()


  • Dental unfilled resin sealant/coating
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution

  • 00858012005878 ()
DSC014-03-US

  • Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005861 ()
D4D0192

  • Basic diagnostic x-ray system application software
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