QJT

Rigid Sterilization Container With Software

Product code
QJT
Device name
Rigid Sterilization Container With Software
Device class
Class 2
21 CFR
21 CFR 880.6855
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QJT
Classification and pathway per current FDA publications. Data from openFDA (CC0).