Duns Number:308547608
Device Description: The EmbryoSlide culture dish is intended for preparing, storing, and transferring human em The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device.The EmbryoSlide culture dish contains two types of wells: wells, which are only used for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The EmbryoSlide culture dish fits exactly on the culture dish holder in the EmbryoScope time-lapse incubator and holds a maximum of 12 embryos in separate microwells. The EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos and 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation.. Each well has a volume of 25 μl. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 μm.
Catalog Number
FT-S-ES-D
Brand Name
EmbryoSlide culture dish
Version/Model Number
FT-S-ES-D
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150961,K150961
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
de82aa59-8768-4a72-ba85-8f1467f8af51
Public Version Date
March 10, 2021
Public Version Number
4
DI Record Publish Date
August 26, 2016
Package DI Number
15712714663502
Quantity per Package
50
Contains DI Package
05712714663505
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| 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 |