Product Code: EXG FDA class 1 21 CFR 876.5900

Bag, Urine Collecting, Ureterostomy

Gastroenterology, Urology

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.

510(k)s
0
FEI Numbers
59
Registration Numbers
59
Unique Applicants
0
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.