NNX — Device, Incontinence, Urosheath Type, Non-Sterile Class I

FDA Device Classification

FDA product code NNX covers "Device, Incontinence, Urosheath Type, Non-Sterile", a Class I medical device regulated under 21 CFR 876.5250. Submissions are reviewed by the Gastroenterology, Urology panel.

Classification Details

Product Code
NNX
Device Class
Class I
Regulation Number
876.5250
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

Urine collector and accessories; see product code EXJ