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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture, intravaginal, assisted reproduction
Definition Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.
Product CodeOYO
Regulation Number 884.6165
Device Class 2


Premarket Reviews
ManufacturerDecision
INVO BIOSCIENCE
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1

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