FDA.report

Saalt Menstrual Cup

Primary DI
00810050720786
Brand
Saalt Menstrual Cup
Company
Saalt, LLC
Model
SC0017R
Device description
Saalt Cup Twin Pack Regular
Published
2022-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HHECup, Menstrual

Product Code Classifications

CodeDeviceSpecialtyClass
HHECup, MenstrualObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810050720786PrimaryGS10

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 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

Regulatory Flags

DUNS number
117603872
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00810050720755Saalt Menstrual CupSC0015R2022-03-30
00810050720762Saalt Menstrual CupSC0014R2022-03-30
00810050720779Saalt Menstrual CupSC0016R2022-03-30
00810050722063Saalt Menstrual DiscSD0001R2022-03-30
00810050722070Saalt Menstrual DiscSD0002R2022-03-30
00851705008002Saalt Menstrual CupSC0002R2022-03-30
00851705008040Saalt Menstrual CupSC0003R2022-03-30
00851705008057Saalt Menstrual CupSmall Blue Regular Pink2022-03-30
00851705008071Saalt Menstrual CupSC0052R2022-03-30
00851705008101Saalt Menstrual CupSC0005R2022-03-30
00851705008118Saalt Menstrual CupSC0006R2022-03-30
00851705008125Saalt Menstrual CupSC0007R2022-03-30
00851705008132Saalt Menstrual CupSC0008R2022-03-30
00851705008149Saalt Menstrual CupSC0011R2022-03-30
00851705008163Saalt Menstrual CupSC00102022-03-30
00851705008958Saalt Menstrual CupSC0013R2022-03-30
00810050720823Saalt Teen Menstrual CupTeen Wild Rose2022-03-29
00851705008019Saalt Menstrual CupSC0001R2022-03-29
00851705008033Saalt Menstrual CupSC0004R2022-03-29
00851705008170Saalt Menstrual CupSC0009R2022-03-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860012792801LunableYayoi FemTech Inc.HHE2025-09-02
00841445001326DivaCup ImpactDiva International IncHHE2025-09-01
00841445001333DivaCup ImpactDiva International IncHHE2025-09-01
00841445001340DivaCup ImpactDiva International IncHHE2025-09-01
00850068130221Pixie CupPixie Cup LLCHHE2025-08-02
00860417001393Pixie CupPixie Cup LLCHHE2025-06-26
00869352000348Pixie CupPixie Cup LLCHHE2025-06-26
00715875074840Pixie CupPixie Cup LLCHHE2025-06-25
00850016867742Pixie CupPixie Cup LLCHHE2025-06-25
00860013832001Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832018Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832025Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
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
07898976999113Mestrual cup Pink Love HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
00311917057415WalgreensWALGREEN CO.HHE2025-05-16
00311917057446WalgreensWALGREEN CO.HHE2025-05-16
00850066493052Casco CupCASCO BAY MOLDING LTD.HHE2025-02-07
09420060212013SensiCup - Frosted - 20ml - 1pcTHINK GREEN LIMITEDHHE2024-12-17