Duns Number:752103403
Device Description: The Gems Cleavage Medium is intended for culture of embryos from fertilization to cleavage The Gems Cleavage Medium is intended for culture of embryos from fertilization to cleavage stage and transfer of embryos to the uterus.
Catalog Number
-
Brand Name
Gems Cleavage Medium
Version/Model Number
CLM-20
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
K161261
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
8ae10921-8543-412e-9f1c-2b9703be43b3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 11, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |