Product code FMK

Device name

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

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4850

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

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.

Source

FDA openFDA device classification dataset