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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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Cycler Control - 00858637005321

No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005321 ()


  • Laboratory instrument/analyser application software IVD

Cologuard Test Definition v1.3 - 00858637005277

No Description
EXACT SCIENCES CORPORATION
1.3
Not in Commercial Distribution

  • 00858637005277 ()


  • Laboratory instrument/analyser application software IVD

Reader Control - 00858637005246

No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005246 ()


  • Laboratory instrument/analyser application software IVD

STARlet Interface - 00858637005239

No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005239 ()


  • Laboratory instrument/analyser application software IVD

Analytical Server - 00858637005222

No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005222 ()


  • Laboratory instrument/analyser application software IVD

Analytical Client - 00858637005215

No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005215 ()


  • Laboratory instrument/analyser application software IVD

Mediworks - 06945087505175

No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Scansys TA517
In Commercial Distribution

  • 06945087505175 ()


  • Eye anterior segment analyser

AWARE DART iOS Client - 00850893007033

Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.
AMBIENT CLINICAL ANALYTICS, INC.
1.0
In Commercial Distribution

  • 00850893007033 ()


  • Clinical management support software

AWARE DART - 00850893007026

Clinical decision support software for disease detection and response indicated for use by licensed clinicians in a clinical setting.
AMBIENT CLINICAL ANALYTICS, INC.
1.1
In Commercial Distribution

  • 00850893007026 ()


  • Clinical management support software

AWARE - 00850893007019

Clinical decision support software indicated for use by licensed clinicians in a clinical setting integrated with Philips ICCA product.
AMBIENT CLINICAL ANALYTICS, INC.
P1.0
In Commercial Distribution

  • 00850893007019 ()


  • Clinical management support software
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