Duns Number:308547608
Device Description: The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containin The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reservoir has eight culture wells, and each well is used to culture one embryo. Therefore, a total of 16 embryos can be cultured on one dish. Each dish includes four special wells that are only used for rinsing and handling the embryos either before or after incubation. An adhesive barcode label printed from the EmbryoViewer software is used to mark each dish. The barcode label contains two different 2D data matrices that provide information on the patient (name, patient ID, treatment ID, and insemination time). The EmbryoSlide+ culture dish has a sterility assurance level of 10-6 and a shelf-life of four years. This device is subject to mouse embryo assay (MEA) and endotoxin testing before lot release.
Catalog Number
16450
Brand Name
EmbryoSlide+ culture dish
Version/Model Number
16450
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
K173264,K173264
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
c3101a2e-301b-4b2a-a5a8-04a3639a1e8d
Public Version Date
March 10, 2021
Public Version Number
3
DI Record Publish Date
May 24, 2018
Package DI Number
15712714664509
Quantity per Package
40
Contains DI Package
05712714664502
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 |