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