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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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Sonova Brand - 07613389430257

myPhonak 5.0 app
Sonova AG
088-0014-18
In Commercial Distribution

  • 07613389430257 ()
088-0014-18

  • Audiometric/hearing device software

Sonova Brand - 07613389430240

myPhonak 5.0 app
Sonova AG
088-0014-70
In Commercial Distribution

  • 07613389430240 ()
088-0014-70

  • Audiometric/hearing device software

Sonova Brand - 07613389430233

myPhonak 5.0 app
Sonova AG
088-0014-21
In Commercial Distribution

  • 07613389430233 ()
088-0014-21

  • Audiometric/hearing device software

Phonak Brand - 07613389417319

DVD Phonak Target 7.1
Sonova AG
058-0125-071
In Commercial Distribution

  • 07613389417319 ()
058-0125-071

  • Audiometric/hearing device software

PeriWatch Vigilance® Cues™ - B087PATT22011

PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
22.01.xx
In Commercial Distribution

  • B087PATT22011 ()


  • Obstetrical monitoring/analysis software

PeriWatch Vigilance® Cues™ - B087PATT202421

PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
2024.2.xxx
In Commercial Distribution

  • B087PATT202421 ()


  • Obstetrical monitoring/analysis software

PeriWatch Vigilance® Cues™ - B087PATT202411

PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
2024.1.xxx
In Commercial Distribution

  • B087PATT202411 ()


  • Obstetrical monitoring/analysis software

PeriWatch Vigilance® Cues™ - B087PATT02121

PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.12.xx
In Commercial Distribution

  • B087PATT02121 ()


  • Obstetrical monitoring/analysis software

PeriWatch™ Cues™ - B087PATT02081

PeriWatch™ Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.08.xx
In Commercial Distribution

  • B087PATT02081 ()


  • Obstetrical monitoring/analysis software

PeriCALM® Patterns™ - B087PATT02041

PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.04.xx
In Commercial Distribution

  • B087PATT02041 ()


  • Obstetrical monitoring/analysis software
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