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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electronic depth gauge
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue. It may enable the proper sizing of screws and implants in medical procedures.
Product CodeOOL
Regulation Number 888.3030
Device Class 2