# Device, Incontinence, Urosheath Type, Non-Sterile
> **Product code: NNX** · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5250
## Classification
- **FDA Product Code:** NNX
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 876.5250
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 4
- **GMP exempt:** Y
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Urine collector and accessories; see product code EXJ

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 32
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NNX)
---
*AI Analytics · CC0 1.0*