Product code
QIX: System, transdermal delivery, cder or cber led
FDA product code · Not Classified · General Hospital
Key facts
| Product code | QIX |
|---|---|
| Device | System, transdermal delivery, cder or cber led |
| Device class | Not Classified |
| Review panel | General Hospital |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Drug delivery systems designed to deliver at least one therapeutically active ingredient (drug substance) across the skin for systemic effect. |
At a glance
- None 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