Duns Number:060467826
Device Description: KWIK-STIK™ B. multivorans ATCC BAA-247™
Catalog Number
01270U
Brand Name
KWIK-STIK™
Version/Model Number
01270U
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JTR
Product Code Name
KIT, QUALITY CONTROL FOR CULTURE MEDIA
Public Device Record Key
76a0c581-57ac-4120-84b3-977a0dc45398
Public Version Date
May 08, 2020
Public Version Number
1
DI Record Publish Date
April 30, 2020
Package DI Number
20845357042662
Quantity per Package
2
Contains DI Package
10845357042665
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
2 Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1104 |
2 | A medical device with a moderate to high risk that requires special controls. | 24 |