Product code
QUJ: Automated cryopreservation storage system
FDA product code · Class II · Obstetrics/Gynecology
Key facts
| Product code | QUJ |
|---|---|
| Device | Automated cryopreservation storage system |
| Device class | Class II |
| Regulation number | 884.6120 |
| Review panel | Obstetrics/Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database