510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NURClass I

Pad, Menstrual, Intralabial

21 CFR 884.5435 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

NUR is the FDA product code for Pad, Menstrual, Intralabial, a class I device type, regulated under 21 CFR 884.5435. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NUR
Device name
Pad, Menstrual, Intralabial
FDA 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.
Regulation
21 CFR 884.5435
Device class
Class I
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code