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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bur, ent, diamond coated, single use, reprocessed
Regulation Description Ear, nose, and throat bur.
Definition ENT diamond bur is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection.
Product CodeNLZ
Regulation Number 874.4140
Device Class 1