FDA.reportPublic FDA data

SensiCup - Frosted - 20ml - 1pc

Primary DI
09420060212013
Brand
SensiCup - Frosted - 20ml - 1pc
Company
THINK GREEN LIMITED
Model
MHK171-C
Published
2024-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HHECup, Menstrual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHECup, MenstrualObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420060212013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420060212013094200602120139420060212013

GMDN Terms#

Term, Definition table
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 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 table
Method

Regulatory Flags#

DUNS number
595005923
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09420060212020SensiCup - Frosted - 20ml - 2pcsMHK172-C2024-12-17
09420060212037SensiCup - Frosted - 25ml - 1pcMHK173-C2024-12-17
09420060212044SensiCup - Frosted - 25ml - 2pcsMHK174-C2024-12-12
09420060203028Ladybug Silicone Breast Milk Collector - 150mlMHK0872024-12-18
09420060203035Ladybug Silicone Breast Milk Collectors (150ml) - 2pcsMHK0882024-12-18
09420060203042Ladybug Silicone Breast Milk Collectors (75ml) - 2pcsMHK1002024-12-18
09420060208030Silicone Finger BrushBHK0272024-12-18
09420060210071Silicone Dinky Digits Palm TeetherTPS0182024-12-18
09420060202021Silicone Nipple Shields (2pcs)AMZ0092024-12-17
09420060202069Breastfeeding Nipple Shield - Orthodontic Teat (Triangle Base)MHK0822024-12-17
09420060202076Breastfeeding Nipple Shield - Orthodontic Teat (Round Base)MHK0832024-12-17
09420060202083BreastFeeding Nipple Shield - Butterfly ShapeMHK0382024-12-17
09420060202090Flexi Silicone Nipple ShieldsMHK0812024-12-17
09420060203011Ladybug Silicone Breast Milk Collector - 75mlMHK0842024-12-17
09420060203059Ladybug Silicone Breast Milk Collectors (40ml) - 2pcsMHK1442024-12-17
09420060203066Ladybug Silicone Breast Milk Collector - 40mlMHK1432024-12-17
09420060204018Silicone Colostrum Collector (pre-sterilised) - 1pcMHK1402024-12-17
09420060204025Silicone Colostrum Collector (pre-sterilised) - 2pcsMHK1422024-12-17
09420060204032Silicone Colostrum Collector (pre-sterilised) - 20ml - 1pcMHK1572024-12-17
09420060204049Silicone Colostrum Collector (pre-sterilised) - 20ml - 2pcsMHK1582024-12-17

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00860012792801LunableYayoi FemTech Inc.HHE2025-09-02
00841445001326DivaCup ImpactDiva International IncHHE2025-09-01
00841445001333DivaCup ImpactDiva International IncHHE2025-09-01
00841445001340DivaCup ImpactDiva International IncHHE2025-09-01
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00850016867742Pixie CupPixie Cup LLCHHE2025-06-25
00850016867780Pixie CupPixie Cup LLCHHE2025-06-24
00860013832001Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832018Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832025Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00850037498420FlexThe Flex CompanyHHE2025-06-12
10850037498427FlexThe Flex CompanyHHE2025-06-12
09421907199696Hello PeriodTHE HELLO CUP COMPANY LIMITEDHHE2025-06-10
07898976999007Mestrual disc clear SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999014Mestrual disc clear MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999021Mestrual disc clear HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999038Mestrual disc Pink Love SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999045Mestrual disc Pink Love MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999052Mestrual disc Pink Love HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999069Mestrual disc Unicorn SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999076Mestrual disc Unicorn MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999083Mestrual disc Unicorn HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999090Mestrual cup Pink Love SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999106Mestrual cup Pink Love MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09