Duns Number:118793157
Catalog Number
-
Brand Name
CTS™ OpTmizer™ T-Cell Expansion Basal Medium
Version/Model Number
A3704001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 12, 2020
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
K113566,K113566
Product Code
NDS
Product Code Name
MEDIA, CULTURE, EX VIVO, TISSUE AND CELL
Public Device Record Key
7c709e70-ef89-4cbf-97b6-d314f17aa99b
Public Version Date
August 13, 2020
Public Version Number
6
DI Record Publish Date
June 15, 2018
Package DI Number
30190302014278
Quantity per Package
6
Contains DI Package
10190302014274
Package Discontinue Date
August 12, 2020
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 634 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| 3 | A medical device with high risk that requires premarket approval | 12 |