Duns Number:308547608
Device Description: The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for transfer.The EmbryoSlide+ ic8 dish has 8 culture wells, each to be used for storing a single embryo in individual culture in a microwell inside the well, providing a capacity of 8 embryos. Each well holds 20µL medium. In addition, four rinsing wells are available and can optionally be used if applicable in the specific clinic workflow. Each rinsing well holds 25-30µL medium. The culture area of the dish comprising both culture wells and rinsing wells must be covered with 1.6mL culture oil overlay which will reduce osmolarity changes during culture in a dry environment.The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has a sterility assurance level of 10-6 and is subject to Mouse Embryo Assay (MEA) and endotoxin testing before lot release.The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.
Catalog Number
16455
Brand Name
EmbryoSlide+ ic8 dish
Version/Model Number
16455
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
K213869,K213869
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
0e435adb-466e-47f3-b384-d212900c2920
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 20, 2022
Package DI Number
15712714000048
Quantity per Package
40
Contains DI Package
05712714000041
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard 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 |