Bag, Urine Collecting, Ureterostomy
The ureterostomy urine collecting bag is a collection device worn externally to collect urine from a ureterostomy stoma, where one or both ureters have been diverted directly through the abdominal wall. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is EXG, regulated under 21 CFR 876.5900 in the Gastroenterology, Urology specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- EXG
- Device Class
- FDA class 1
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 59 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 59 registration numbers. Click on an entry to view related FDA registrations.