Rigid Sterilization Container With Software
QJT is the FDA product code for Rigid Sterilization Container With Software, a class II device type, regulated under 21 CFR 880.6855. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QJT
- Device name
- Rigid Sterilization Container With Software
- 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.
- Regulation
- 21 CFR 880.6855
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QJT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2022 | 1 |
Applicants with the most clearances
Product code QJT| Applicant | Clearances |
|---|---|
| Zuno Medical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QJT.
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