Duns Number:657528899
Device Description: Mini Ovulation Microscope for Smartphone is to observe the density of fern crystallization Mini Ovulation Microscope for Smartphone is to observe the density of fern crystallization from your saliva(NaCI) to determine whether or not has ovulated.
Catalog Number
-
Brand Name
NA
Version/Model Number
U-TW1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LHD
Product Code Name
Device, Fertility Diagnostic, Proceptive
Public Device Record Key
577ccf46-80de-49ba-bfa7-c0bbacde0d4a
Public Version Date
June 25, 2020
Public Version Number
3
DI Record Publish Date
August 18, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 676 |
| U | Unclassified | 1 |