The Keeper

GUDID 00787010222218

The Keeper Menstrual Cup Size A

GLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC

Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable Menstrual cup, non-latex, reusable
Primary Device ID00787010222218
NIH Device Record Key3bff5887-22aa-4b1a-984c-24a54a0fb170
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Keeper
Version Model NumberKA
Company DUNS948902387
Company NameGLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100787010222218 [Primary]

FDA Product Code

HHECup, Menstrual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-21