Duns Number:008965063
Device Description: WALG MENSTRUAL CUP MODEL 2. A menstrual cup is a feminine hygiene device that is inserted WALG MENSTRUAL CUP MODEL 2. A menstrual cup is a feminine hygiene device that is inserted into the vagina during menstruation. Purpose is to collect menstrual fluid and prevent leaking onto clothes. Made of flexible medical grade silicone and shaped like a bell with a stem. Stem is used for insertion and removal. The bell-shaped cup seals against the vaginal wall just below the cervix. Every 4–12 hours, the cup is removed, emptied, rinsed, and reinserted. After each period, the cup should be boiled for at least 5 minutes and stored for use the next month.
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
283416
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HHE
Product Code Name
Cup, Menstrual
Public Device Record Key
6de9c1a3-193b-42cb-84c2-6f74a21d90a6
Public Version Date
December 11, 2020
Public Version Number
1
DI Record Publish Date
December 03, 2020
Package DI Number
10049022047942
Quantity per Package
12
Contains DI Package
00049022047945
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |