Product code PVZ

Device name

Non-Stainless Steel Needle

Medical specialty

General Hospital

Device class

2

Regulation number

880.5570

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Definition

A hypodermic needle is intended to inject medication and aspirate fluid, below the surface of the skin. Designed to be used with ultrasound for better visualization of needle during use.

Source

FDA openFDA device classification dataset