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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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BEIGE/990013-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990013-SWH
In Commercial Distribution

  • 00850016231130 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990005-SWH; left replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990005-SWH
In Commercial Distribution

  • 00850016231055 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990004-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990004-SWH
In Commercial Distribution

  • 00850016231048 ()


  • Air-conduction hearing aid, receiver-in-canal
InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest.
Infervision Medical Technology Co., Ltd
5.0.2.5
In Commercial Distribution

  • 00850003095042 ()


  • X-ray image interpretive software
  • Diagnostic x-ray digital imaging system workstation
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH).
Infervision US Inc
1.1.0.0
In Commercial Distribution

  • 00850003095011 ()


  • Diagnostic x-ray digital imaging system workstation
  • X-ray image interpretive software
Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest.
Infervision US Inc
2.1.2.1
In Commercial Distribution

  • 00850003095004 ()


  • X-ray image interpretive software
  • Diagnostic x-ray digital imaging system workstation
Quantum Blue nitrile exam gloves, cobalt blue, x-large, 100/box
SAFCO DENTAL SUPPLY CO.
8210005
In Commercial Distribution

  • 00810063754938 ()
  • 10810063754935 ()
KXL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Quantum Blue nitrile exam gloves, cobalt blue, large, 100/box
SAFCO DENTAL SUPPLY CO.
8210004
In Commercial Distribution

  • 00810063754921 ()
  • 10810063754928 ()
KL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Quantum Blue nitrile exam gloves, cobalt blue, medium, 100/box
SAFCO DENTAL SUPPLY CO.
8210003
In Commercial Distribution

  • 00810063754914 ()
  • 10810063754911 ()
KM

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Quantum Blue nitrile exam gloves, cobalt blue, small, 100/box
SAFCO DENTAL SUPPLY CO.
8210002
In Commercial Distribution

  • 00810063754907 ()
  • 10810063754904 ()
KS

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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