Device, Paste-on For Incontinence, Non-sterile

Device Code: 2037

Product Code(s): NOA

Definition: Urine Collector And Accessories; See Product Code EXI.

Device Classification Information

Device Type ID2037
Device NameDevice, Paste-on For Incontinence, Non-sterile
Regulation DescriptionUrine Collector And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Urology And Lithotripsy Devices Branch (ULDB)
Submission Type510(K) Exempt
CFR Regulation Number876.5250 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNOA
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2037
DeviceDevice, Paste-on For Incontinence, Non-sterile
Product CodeNOA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionUrine Collector And Accessories.
CFR Regulation Number876.5250 [🔎]
TPLC Last Update: 2019-04-02 20:04:49

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