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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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GI Genius - 10884521844537

GGI Genius (TM) System 100
Covidien LP
GGS100
In Commercial Distribution

  • 10884521844537 ()

  • Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit

GI Genius - 10884521821545

Intelligent Endoscopy Module , Refurbished
Covidien LP
CB1708-RFB
In Commercial Distribution

  • 10884521821545 ()


  • Endoscopic video image interpretive unit

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

ACUMED - 10806378039850

AI Acutrak® Comp Screw Handle Assy
Acumed LLC
80-0097
In Commercial Distribution

  • 10806378039850 ()


  • Surgical instrument handle, non-torque-limiting

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
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