Product code QNS

Device name

Low Dead Space Needle, Single Lumen, Hypodermic

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

N

Summary malfunction reporting

Ineligible

Definition

A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.

Source

FDA openFDA device classification dataset