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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
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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