Duns Number:118793157
Catalog Number
-
Brand Name
KnockOut™ Serum Replacement
Version/Model Number
10828028
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 07, 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
K100616,K100616
Product Code
NDS
Product Code Name
MEDIA, CULTURE, EX VIVO, TISSUE AND CELL
Public Device Record Key
3c6446b8-06fe-4e2c-8bba-e33a54006df5
Public Version Date
August 10, 2020
Public Version Number
7
DI Record Publish Date
August 01, 2016
Package DI Number
30190302001582
Quantity per Package
10
Contains DI Package
10190302001588
Package Discontinue Date
August 07, 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 |