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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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Sontro Self-Fitting OTC Hearing Aids - 00850016231048

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

Sontro Self-Fitting OTC Hearing Aids - 00850016231055

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

InferRead Lung CT.AI 2.1.2.1 - 00850003095004

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

InferRead Lung CT.AI - 00850003095042

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 - 00850003095011

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

QUANTUM™ CT Overlay - 10841962109052

Quantum CT - Siemens Somatom Definition 64 (for 240cm long cradle)
Qfix
RT-4550SS3
In Commercial Distribution

  • 10841962109052 ()

  • Length: 240 Centimeter
RT-4550SS3

  • Indexed-immobilization patient positioning system

APO CAL - 05055273204414

This product is intended for in-vitro use in the calibration of Apolipoprotein A-I and Apolipoprotein B assays.
RANDOX LABORATORIES LIMITED
LP3023
In Commercial Distribution

  • 05055273204414 ()
LP3023

  • Multiple apolipoprotein IVD, calibrator

Sontro Self-Fitting OTC Hearing Aids - 00850016231161

BEIGE/990016-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990016-SWH
In Commercial Distribution

  • 00850016231161 ()


  • Air-conduction hearing aid, receiver-in-canal

Sontro Self-Fitting OTC Hearing Aids - 00850016231079

GREY/990007-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990007-SWH
In Commercial Distribution

  • 00850016231079 ()


  • Air-conduction hearing aid, receiver-in-canal

Sontro Self-Fitting OTC Hearing Aids - 00850016231178

BEIGE/990017-SWH; left (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990017-SWH
In Commercial Distribution

  • 00850016231178 ()


  • Air-conduction hearing aid, receiver-in-canal
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