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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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Millennium - 00190776209667

Visual Obturator with AI sheath scope lock
Avalign Technologies, Inc.
72-3130073
In Commercial Distribution

  • 00190776209667 ()


  • ENT examination/treatment system

Millennium - 00190776189686

FIBER OPTIC CABLE FOR RETRACTORS AI ADAPTOR
Avalign Technologies, Inc.
MFOC-10R
In Commercial Distribution

  • 00190776189686 ()


  • Electrical-only medical device connection cable, reusable

Millennium - 00190776189570

Fiberoptic Cable A AF Blue AI Cable
Avalign Technologies, Inc.
FTIMG166288BL
In Commercial Distribution

  • 00190776189570 ()


  • Electrical-only medical device connection cable, reusable

Millennium - 00190776191177

FIBER LIGHT CABLE w AI INSTRUMENT CONNECTORS
Avalign Technologies, Inc.
72-9819
In Commercial Distribution

  • 00190776191177 ()


  • Fibreoptic retractor handle

Vital Signs - 10885403257001

CAPNOSTAT Adult/Pediatric Ai rway Adapter, Reusable
Carefusion Finland 320 Oy
412341-001
Not in Commercial Distribution

  • 10885403257001 ()
412341-001

  • Carbon dioxide cuvette, reusable

NA - 07630031759030

Optiloc® Laboratory Instrument, stainless steel/AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution

  • 07630031759030 ()
3202.0002-OPT

  • Dental precision attachment fitting/adjustment tool

AEYE Health - 00850035651032

AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
In Commercial Distribution



  • Retinal image analysis software

AEYE Health - 00850035651018

AEYE-DS-Epic is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS-Epic is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR) and is integrated with the Epic EMR.
Aeye Health, Inc.
AEYE-DS-Epic
Not in Commercial Distribution

  • 00850035651018 ()


  • Retinal image analysis software

AEYE Health - 00850035651001

AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
Not in Commercial Distribution

  • 00850035651001 ()


  • Retinal image analysis software

IDx-DR - 00860005195626

No Description
Digital Diagnostics Inc.
v2.3
In Commercial Distribution

  • 00860005195626 ()


  • Retinal image analysis software
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