Duns Number:308547608
Device Description: The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. T The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The sixteen (16) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture.The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6).Indications for Use / Intended Use:For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.
Catalog Number
16606
Brand Name
Micro well group culture dish, 16-well
Version/Model Number
16606
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
K150756,K150756
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
5caf3a36-d222-4a8a-84b1-467d1a09e7a7
Public Version Date
March 10, 2021
Public Version Number
4
DI Record Publish Date
September 21, 2017
Package DI Number
15712714666060
Quantity per Package
10
Contains DI Package
05712714666063
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Card board 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 |