Pad, Interlabial

Device Code: 4048

Product Code(s): NUR

Definition: A Interlabial Pad Made Of Cellulosic Or Synthetic Material Which Is Placed Over The Vaginal Introitus To Absorb Menstrual Fluid Or Other Vaginal Discharge.

Device Classification Information

Device Type ID4048
Device NamePad, Interlabial
Regulation DescriptionUnscented Menstrual Pad.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission Type510(K) Exempt
CFR Regulation Number884.5435 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNUR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4048
DevicePad, Interlabial
Product CodeNUR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionUnscented Menstrual Pad.
CFR Regulation Number884.5435 [🔎]
TPLC Last Update: 2019-04-02 20:42:10

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