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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device foley catheters and accessories with additional safety features
Regulation Description Urological catheter and accessories.
Definition Foley catheters intended for urine drainage with additional safety features to reduce potential injury to the urethra and/or bladder. These catheters do not include design features intended to reduce infections.
Product CodeSCT
Regulation Number 876.5130
Device Class 2

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