FDA product code NUR: Pad, Menstrual, Intralabial
NUR is the FDA product code for pad, menstrual, intralabial. It is a Class I device, regulated under 21 CFR 884.5435 and reviewed by the Obstetrics and Gynecology panel. Devices under NUR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
An unscented menstrual pad intended as an intralabial pad, which is placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile.
Classification
| Field | Value |
|---|---|
| Device name | Pad, Menstrual, Intralabial |
| Device class | Class I |
| Regulation | 21 CFR 884.5435 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for NUR devices
openFDA lists no recalls for product code NUR.
Frequently asked questions
What is FDA product code NUR?
NUR is the FDA product code for pad, menstrual, intralabial. It is a Class I device, regulated under 21 CFR 884.5435 and reviewed by the Obstetrics and Gynecology panel.
What device class is NUR?
Class I, regulation 21 CFR 884.5435. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NUR
- Run a recall and safety report across every NUR manufacturer
- Watch product code NUR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Obstetrics and Gynecology product codes · FDA product code lookup