Product code QRK

Device name

Single Use Only Blood Lancet Without 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

Ineligible

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.

Source

FDA openFDA device classification dataset