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INVOcell Retention Device

INVO BIOSCIENCE, INC. · Model P-017 · UDI-DI 00862190000341

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510(k) clearances

Adverse events

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Description

The INVOcell Retention Device is a single-use, modified diaphragm that includes holes to allow for natural drainage of vaginal fluids. The retention device is placed into the vaginal cavity with the INVOcell Culture Device to ensure that the INVOcell Culture Device is retained in the vaginal cavity for 72 hours. The INVOcell Retention Device is a commercially-available diaphragm made of medical grade silicone.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.