inforMED
QJTClass II

Rigid Sterilization Container With Software

General Hospital · 21 CFR 880.6855

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.

MDR events1All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time

Event type breakdown

Malfunction1

Recalls

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Registered firms

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