Product code PEC

Device name

Sterilizer Automated Loading System

Medical specialty

General Hospital

Device class

2

Regulation number

880.6880

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer.

Source

FDA openFDA device classification dataset