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16 FDA 510(k) clearances · Product code

FDA profile

Official device name

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4850

Medical specialty

General, Plastic Surgery

FDA definition

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

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