Duns Number:440514105
Device Description: Reusable menstrual cup 100% certified medical grade soft hypoallergenic silicone modern, Reusable menstrual cup 100% certified medical grade soft hypoallergenic silicone modern, safe, eco-friendly, economical.Includes:o 1 Mamicupo 1 cotton storage poucho 1 user instructionsMamicup is the first menstrual cup 100% made in Italy redesigned to collect your menstrual blood naturally and hygienically. Simply fold it, insert it in your vagina and empty it every 4 to 8 hours. Made of certified medical grade soft platinic silicone, it helps avoiding irritations, allergies and inconveniences and lasts up to 5-10 years. It is modern, safe, ecological, economical and makes the period nicer! Suitable also for the night and for sports and travel. Easy to use and clean.
Catalog Number
-
Brand Name
Mamicup®
Version/Model Number
Size L - Lilac
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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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
f2d1fb73-efd2-4e22-add3-ab67e4a779a9
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
April 15, 2020
Package DI Number
18055349618071
Quantity per Package
6
Contains DI Package
08055349618074
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-