QJT

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Rigid Sterilization Container With Software

Device class

Class II (moderate risk)

Regulation

21 CFR 880.6855

Medical specialty

General Hospital

FDA 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.

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