Pad, Menstrual, Unscented

Device Code: 3963

Product Code(s): HHD

Device Classification Information

Device Type ID3963
Device NamePad, Menstrual, Unscented
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 CodeHHD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3963
DevicePad, Menstrual, Unscented
Product CodeHHD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionUnscented Menstrual Pad.
CFR Regulation Number884.5435 [🔎]
Device Problems
Insufficient Information
1
Patient-Device Incompatibility
1
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 20:40:48

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