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

FDA product code FMK · 111 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4850
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1981-02-04 – 2026-09-13

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.

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