Device, Paste-On For Incontinence, Non-Sterile
The non-sterile paste-on incontinence device is a urological product used externally to manage male urinary incontinence by adhering to the skin and directing urine flow into a collection system. It is classified as FDA Class 1 under regulation 876.5250 in the Gastroenterology and Urology specialty, and it is GMP exempt. Product code NOA does not require a 510(k) submission and is associated with product code EXI.
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Basic Information
- Product Code
- NOA
- 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 EXI.
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.