FDA.report

Super Jennie

Primary DI
08174530204138
Brand
Super Jennie
Company
Anigan Inc.
Model
Teal 2
Device description
Super Jennie menstrual cup is a soft device made of medical grade silicone. It is to be placed by the user into the vagina to collect blood during menstruation.
Published
2019-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HHECup, menstrual

Product Code Classifications

CodeDeviceSpecialtyClass
HHECup, MenstrualObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08174530204138PrimaryGS10

GMDN Terms

TermDefinition
Menstrual cup, non-latex, reusableA cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(999)999-9999customerservice@anigan.com

Regulatory Flags

DUNS number
012179121
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00817453020437Super JennieBlue 2SJ0052020-03-12
00817453020406Super JennieTeal 1SJ0012019-06-25
00817453020413Super JennieTeal 2SJ0022019-06-25
00817453020826EvaCupPink 1EVA0012019-06-25
00817453020833EvaCupPink 2EVA0022019-06-25
00817453021168Super JenniePink 2SJ0042019-06-25
00817453021175Super JenniePink 1SJ0032019-06-25
00817453022035EvaCupCherry Blossom 1EVA0032019-08-05
00817453022042EvaCupCherry Blossom 2EVA0042019-08-05
08174530204060Super JennieTeal 12019-06-25
08174530208266EvaCupPink 12019-06-25
08174530208334EvaCupPink 22019-06-25
08174530211686Super JenniePink 22019-06-25
08174530211754Super JenniePink 12019-06-25

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