QJT · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6855
Classification
FDA Product Code
QJT
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6855
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.