NUR · Class I — Low Risk (general controls) · Obstetrics/Gynecology · 21 CFR 884.5435
Classification
FDA Product Code
NUR
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 884.5435
Review panel
OB
Medical specialty
Obstetrics/Gynecology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
An unscented menstrual pad intended as an intralabial pad, which is placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile.