Multiple Use Blood Lancet For Multiple Patient Use
QRM · Class III — High Risk (PMA approval required, life-sustaining) · General, Plastic Surgery · 21 CFR 878.4850
Classification
FDA Product Code
QRM
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 878.4850
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.