Device type

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product code FMK · Class II · 21 CFR 878.4850 · General, Plastic Surgery

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

FDA classification database