Product code
NNX: Device, incontinence, urosheath type, non-sterile
FDA product code · Class I · Gastroenterology/Urology
Key facts
| Product code | NNX |
|---|---|
| Device | Device, incontinence, urosheath type, non-sterile |
| Device class | Class I |
| Regulation number | 876.5250 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | Gastroenterology/Urology |
| Submission type | 510(K) Exempt |
| GMP exempt | Yes |
| Definition | Urine collector and accessories; see product code EXJ |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 100–999 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