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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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SKOUT system - 00860010168400

The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps. The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time.
Iterative Scopes, Inc.
SKOUT200
In Commercial Distribution

  • 00860010168400 ()


  • Endoscopic video image interpretive unit

GI Genius™ Module 300 - 08055060110338

GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution

  • 08055060110338 ()


  • Endoscopic video image interpretive unit

GI Genius™ Module 200 - 08055060110321

No Description
LINKVERSE SRL
GGM200.US
In Commercial Distribution

  • 08055060110321 ()


  • Endoscopic video image interpretive unit

GI Genius™ Module 100 - 08055060110314

No Description
LINKVERSE SRL
GGM100.US
In Commercial Distribution

  • 08055060110314 ()


  • Endoscopic video image interpretive unit

GI Genius - 10884521807259

Intelligent Endoscopy Module
Covidien LP
CB1708-EU
In Commercial Distribution

  • 10884521807259 ()

  • Voltage, 100- 240, VAC;+/-10%,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

GI Genius - 10884521844544

GGI Genius (TM) System 200
Covidien LP
GGS200
In Commercial Distribution

  • 10884521844544 ()

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


  • Endoscopic video image interpretive unit

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

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
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