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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

Device Problems
Tip breakage 1
Total Device Problems 1