cycleclarity.comNITYR
Nitisinone
CYCLE CLARITY
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3024972425 | 3024972425 | CYCLE CLARITY | 1 | N | 2026-01-01 | 1209 Fifteen Mile Landing Rd. Awendaw SC US 29429 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860008194435 | Cycle Clarity - Follicle Clarity is a cloud-based software application package (Software as a Medical Device, SaMD). It is designed to view and quantify image data acquired on compatible diagnostic ultrasound systems. The software functions as an aid to interpreting clinicians by calculating the number and size of hypoechoic structures (ovarian follicles) in a transvaginal ultrasound volume sweep of the ovaries. | 843-883-6200 | support@cycleclarity.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 310996 | 1659530931 | K212012 | Follicle Clarity | QIH | 2022-01-19 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QIH | 1 | 2022-01-19 |
NDC#
NITYR
Nitisinone
NITYR
Nitisinone
SAJAZIR
ICATIBANT
TASCENSO ODT
Fingolimod Lauryl Sulfate
TASCENSO ODT
Fingolimod Lauryl Sulfate
ORMALVI
Dichlorphenamide
AAGYLUR
Penicillamine
HARLIKU
nitisinone
VENXXIVA
tiopronin
VENXXIVA
tiopronin
PHYRAGO
dasatinib
PHYRAGO
dasatinib
PHYRAGO
dasatinib
PHYRAGO
dasatinib
PHYRAGO
dasatinib
PHYRAGO
dasatinib
PMN#
Follicle Clarity
Cycle Clarity
Every Cycle Reusable Tampon Applicator
Cycle, LLC
CYCLES REUSABLE MENSTRUAL PADS
CYCLES
Applications#
GUDID#
Cycle Clarity - Follicle Clarity is a cloud-based software application package (Software as a Medical Device, SaMD). It is designed to view and quantify image data acquired on compatible diagnostic ultrasound systems. The software functions as an aid to interpreting clinicians by calculating the number and size of hypoechoic structures (ovarian follicles) in a transvaginal ultrasound volume sweep of the ovaries.
2026-05-21
Every Cycle - Every Cycle reusable tampon applicator
2022-03-10