← FDA Medical Device Classifications

Device, Paste-On For Incontinence, Non-Sterile

NOA · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5250

Classification

FDA Product Code
NOA
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 876.5250
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
4
GMP exempt
Y
Life sustaining
N
Implant
N
Third-party review
N

Definition

Urine collector and accessories; see product code EXI.

Market data

Cleared 510(k) submissions
0
Registered establishments
26

Source

Authoritative
FDA Device Classification database
Machine
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