Product code QJT

Device name

Rigid Sterilization Container With Software

Medical specialty

General Hospital

Device class

2

Regulation number

880.6855

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

The rigid sterilization container with software is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility until used. The rigid sterilization container with software is designed for use with high-vacuum or pulse-vacuum steam sterilization systems.

Source

FDA openFDA device classification dataset