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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Polymeric culture device.
Technical Method Culture device designed to hold and maintain gametes and embryos during intravaginal culture procedures.
Target Area Gametes and embryos
Review Panel Obstetrics/Gynecology
Product CodeOYO
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible