FDA.reportPublic FDA data

Frida Fertility

Primary DI
10810028774121
Brand
Frida Fertility
Company
Fridababy, LLC
Model
500001269
Published
2023-12-05
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

Product Codes#

Code, Name table
CodeName
HDRCap, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDRCap, CervicalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222969000FERTI-LILY Conception CupRosesta Medical BV2023-06-23HDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810028774121PackageGS14In Commercial Distribution
00810028774124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002877412110810028774121
00810028774124008100287741248100287741240810028774124

GMDN Terms#

Term, Definition table
TermDefinition
Conceptive cervical cap, reusableA flexible device designed to promote conception, either by serving as a container to introduce semen into the cervix, or by acting as a cervical cup that allows sperm to be held in place for easier access to the cervical os. It is a plastic device that is typically larger, but shallower, than a contraceptive cap. The device is used to aid conception in couples who have experienced difficulties due to low sperm counts, reduced sperm motility or a hostile vaginal environment; and also for self or assisted insemination. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
783729598
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810028777958Frida039001002025-07-12
00810028777965Frida009001002025-07-12
00810028778009Frida014001001000000612025-07-12
10810028770086Frida039001002025-07-12
10810028777962Frida009001002025-07-12
10810028770611Frida014001001000000612025-07-12
00810028770508Frida050014012025-07-02
10810028770505Frida050014012025-07-02
00810028771697Frida025018002025-07-02
00810028776166Frida1000018102024-09-12
10810028774084Frida5000012872024-09-12
00810028774124Frida Fertility5000012692023-12-05
00810028776739Fridababy123001002025-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065015660002Béa FertilitySTEPONE FERTILITY LTDHDR2025-07-24
05065015660064Béa FertilitySTEPONE FERTILITY LTDHDR2025-07-24
00810028774124Frida FertilityFridababy, LLCHDR2023-12-05
03700111400542SMALL GENITOR® INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111400559STANDARD INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111400566INTRA UTERINE INSEMINATION CANNULA WITH MANDRELLABORATOIRE CCDHDR2023-12-05
03700111400573MEMORY INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111400733SPIRETTE®LABORATOIRE CCDHDR2023-12-05
03700111400740MUCAT® STERILELABORATOIRE CCDHDR2023-12-05
03700111425545SMALL GENITOR® INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425552STANDARD INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425569INTRA UTERINE INSEMINATION CANNULA WITH MANDRELLABORATOIRE CCDHDR2023-12-05
03700111425576MEMORY INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425736SPIRETTE®LABORATOIRE CCDHDR2023-12-05
03700111425743MUCAT® STERILELABORATOIRE CCDHDR2023-12-05
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