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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device external urethral occluder, urinary incontinence-control, female
Definition Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.
Product CodeMNG
Regulation Number 876.5160
Device Class 1