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 Type ID | 4048 |
Device Name | Pad, Interlabial |
Regulation Description | Unscented Menstrual Pad. |
Regulation Medical Specialty | Obstetrics/Gynecology |
Review Panel | Obstetrics/Gynecology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 884.5435 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | NUR |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4048 |
Device | Pad, Interlabial |
Product Code | NUR |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Unscented Menstrual Pad. |
CFR Regulation Number | 884.5435 [🔎] |