XO Flo

GUDID 00788832105604

XO Flo Mini

GLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC

Menstrual cup, non-latex, reusable
Primary Device ID00788832105604
NIH Device Record Key65e22af0-d5ce-4f70-83a6-1e3be38114ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameXO Flo
Version Model NumberMini
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100788832105604 [Primary]

FDA Product Code

HHECup, Menstrual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-27
Device Publish Date2018-03-27