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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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Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA 7.0
Not in Commercial Distribution

  • 00862487000320 ()

  • Weight: 7.0 Gram
None

  • Glass ionomer dental cement
  • Endodontic filling/sealing material
Earscan 3 Automatic Threshold Audiometer.
MICRO AUDIOMETRICS CORPORATION
ES3
In Commercial Distribution

  • 00862185000325 ()
05.001

  • Tone audiometer, automated
Earscan 3 Screening Audiometer.
MICRO AUDIOMETRICS CORPORATION
ES3S
In Commercial Distribution

  • 00862185000318 ()
04.001

  • Tone audiometer, manual
Earscan 3 Manual Audiometer.
MICRO AUDIOMETRICS CORPORATION
ES3M
In Commercial Distribution

  • 00862185000301 ()
06.001

  • Tone audiometer, manual
PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves a a decision support tool and electronic medical record.
PERIGEN INC.
2019 Rev 1.02
In Commercial Distribution

  • 00862095000491 ()


  • Obstetrics information system application software
PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves a a decision support tool and electronic medical record.
PERIGEN INC.
2019 Rev 1.02
In Commercial Distribution

  • 00862095000484 ()


  • Obstetrics information system application software
PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves a a decision support tool and electronic medical record.
PERIGEN INC.
2019 Rev 1.01
In Commercial Distribution

  • 00862095000477 ()


  • Obstetrics information system application software
PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves as a decision support tool and electronic medical record.
PERIGEN INC.
2019 Rev 1.0
In Commercial Distribution

  • 00862095000460 ()


  • Obstetrics information system application software
PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves a a decision support tool and electronic medical record.
PERIGEN INC.
2019 Rev 1.00
In Commercial Distribution

  • 00862095000453 ()


  • Obstetrics information system application software
PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves a a decision support tool and electronic medical record.
PERIGEN INC.
2018 Rev 1.00
In Commercial Distribution

  • 00862095000446 ()


  • Obstetrics information system application software
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