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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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CAD/CAM Software - E27666600670

CEREC Software Version 4.6.0
SIRONA Dental Systems GmbH
6660067
In Commercial Distribution

  • E27666600670 ()


  • Dental implant abutment analog, intraoral-scanning, single-use

CAD/CAM Software - E27666129850

CEREC Premium 4.4.4 Software
SIRONA Dental Systems GmbH
6612985
In Commercial Distribution

  • E27666129850 ()


  • Dental implant abutment analog, intraoral-scanning, single-use

CAD/CAM Software - E27666104350

CEREC Premium 4.5.0 Software
SIRONA Dental Systems GmbH
6610435
In Commercial Distribution

  • E27666104350 ()


  • Dental implant abutment analog, intraoral-scanning, single-use

CAD/CAM Software - E27666101610

inLab CAM 16.0 Software
SIRONA Dental Systems GmbH
6610161
In Commercial Distribution

  • E27666101610 ()


  • Dental implant abutment analog, intraoral-scanning, single-use

INTEGRATION BROKER - 03596010589637

SOFTWARE INTEGRATION BROKER HL7
Smith & Nephew, Inc.
72201079
Not in Commercial Distribution

  • 03596010589637 ()
72201079

  • Robotic surgical navigation system application software

N/A - 03596010588371

INTEGRATION SOFTWARE BROKER, DICOM
Smith & Nephew, Inc.
72201081
In Commercial Distribution

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software

DYONICS POWER - 03596010622716

DYONICS II SOFTWARE UPGRADE
Smith & Nephew, Inc.
72202103
In Commercial Distribution

  • 03596010622716 ()
72202103

  • Arthroscopic shaver system, electrically-powered

Centralized Configuration Manager Software - 10711234540121

Centralized Configuration Manager Software
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
000GCCM
In Commercial Distribution

  • 10711234540121 ()
000GCCM

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory

Holter Analysis Software Apnea - M582NEMK1270

Holter Analysis Software Apnea
Northeast Monitoring, Inc.
Holter Analysis Software Apnea
In Commercial Distribution

  • M582NEMK1270 ()
M582NEMK127

  • Cardiac arrhythmia monitoring system

Holter Analysis Software - M581NEMK1630

Holter Analysis Software Pro
Northeast Monitoring, Inc.
Pro
In Commercial Distribution

  • M581NEMK1630 ()
NEMK163

  • Cardiac arrhythmia monitoring system
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