Duns Number:365831125
Device Description: To provide an environment with controlled temperature, CO2 (and other gases) for the devel To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing.
Catalog Number
-
Brand Name
MIRI TL
Version/Model Number
MIRI TL
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
-
Product Code
MQG
Product Code Name
Accessory, Assisted Reproduction
Public Device Record Key
f2ea7fd4-6ec6-4a53-bcff-6c8426e8b193
Public Version Date
September 14, 2020
Public Version Number
3
DI Record Publish Date
October 13, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |