Duns Number:308547608
Device Description: The KIDScore D3 tool provides decision support for prediction of likelihood of embryos dev The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyststage by scoring them according to their statistical viability.Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezingor continued embryo development when, following morphological assessment on Day 3, there are multiple embryosdeemed suitable for transfer or freezing.The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
Catalog Number
16531
Brand Name
KIDScore D3
Version/Model Number
16531
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182798
Product Code
PBH
Product Code Name
Embryo Image Assessment System, Assisted Reproduction
Public Device Record Key
7ae9164c-1b1b-4126-b22c-49c4b7510690
Public Version Date
December 06, 2019
Public Version Number
1
DI Record Publish Date
November 28, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |