Ennie Cup

GUDID 00195893068968

CASCO BAY MOLDING LTD.

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 ID00195893068968
NIH Device Record Key09492ce4-c23b-415f-8030-e58f62a15993
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnnie Cup
Version Model NumberMini
Company DUNS604286695
Company NameCASCO BAY MOLDING LTD.
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 Batchtrue
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
GS100195893068968 [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 Date2022-08-09
Device Publish Date2022-08-01

On-Brand Devices [Ennie Cup]

00195893592753Size 1
00195893093038Size 2
00195893068968Mini

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.