FDA.reportPublic FDA data

Intimina Ziggy Cup

Primary DI
07350075026140
Brand
Intimina Ziggy Cup
Company
Leloi AB
Model
6140
Device description
A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
Published
2017-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
07350075026140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350075026140073500750261407350075026140

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 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 table
Method

Regulatory Flags#

DUNS number
508701849
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350075023453LELO HEX RE-ENGINEERED LATEX CONDOM ORIGINAL - 6 PACK34532022-05-27
07350075024085HEX Condoms Original 36 Pack (US_TNR) 40852022-06-27
07350075024993LELO HEX RE-ENGINEERED LATEX RESPECT CONDOM - 6 PACK49932022-05-26
07350075029578HEX Condoms Original 72 Pack (US_TNR) 95782023-07-10
07350075022470HEX Condoms Original 3 Pack (US_TNR)24722016-09-23
07350075022494HEX Condoms Original 12 Pack (US_TNR)24972016-09-23
07350075024979HEX Condoms Respect 3 Pack (US_FR_TNR) Euroslot49792017-02-09
07350075025006HEX Condoms Respect 12 Pack (US_TNR)50062017-02-09
07350075025020HEX Condoms Respect 36 Pack (US_TNR)50202017-02-09
07350075028557Intimina Ziggy Cup 2 - Size B85572022-05-26
07350075028601Intimina Ziggy Cup 2 - Size A86012022-05-26
07350022276093Intimina Lily Cup Size A - EN60932016-09-21
07350022276109Intimina Lily Cup Size B - EN61092016-09-21
07350022276116Intimina Lily Cup Compact size A - EN61162016-09-21
07350075020117Intimina Lily Cup Compact size B - EN01172016-09-21
07350075020308Intimina Lily Cup Compact Tamaño A - ES03082016-09-21
07350075026065Intimina Lily Cup One60652017-11-07
08852961029796Lelo Hex Lubricated Natural Rubber Latex Condom 3’s3s2025-04-02
08852961029802Lelo Hex Lubricated Natural Rubber Latex Condom 12’s12s2025-04-02
08852961029819Lelo Hex Lubricated Natural Rubber Latex Condom 36’s36s2025-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428087701The DivaCupDiva International IncHHE2026-03-31
00050428088852The DivaCupDiva International IncHHE2026-03-31
00850037498390FlexThe Flex CompanyHHE2025-11-05
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
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