Device, Incontinence, Urosheath Type, Non-Sterile
The non-sterile urosheath-type incontinence device is a urological device used to manage urinary incontinence in male patients by means of an external catheter sheath that collects urine and connects to a drainage bag. It is classified as FDA Class 1 under regulation 876.5250 in the Gastroenterology and Urology specialty, and it is GMP exempt. Product code NNX does not require 510(k) clearance and is associated with product code EXJ.
Research product code NNX in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NNX
- Device Class
- FDA class 1
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
Definition
Urine collector and accessories; see product code EXJ
FEI Numbers
This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.