Duns Number:057475246
Device Description: Chang Medium C with Gentamicin99418-90mL is longer being sold on its own. It can now only Chang Medium C with Gentamicin99418-90mL is longer being sold on its own. It can now only be purchased as part of the 99419-100ml kit.
Catalog Number
99418
Brand Name
Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells
Version/Model Number
99418-90mL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 24, 2022
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KIT
Product Code Name
Media And Components, Synthetic Cell And Tissue Culture
Public Device Record Key
12c32686-c849-4a71-b734-b3da941c6f4a
Public Version Date
February 25, 2022
Public Version Number
4
DI Record Publish Date
December 31, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |