Duns Number:962385787
Device Description: WASH CONCENTRATE
Catalog Number
ST160
Brand Name
CAROLINA LIQUID CHEMISTRIES CORP.® WASH CONCENTRATE ST160
Version/Model Number
ST160
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
-
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
-
Product Code
JCB
Product Code Name
DETERGENT
Public Device Record Key
78494b88-61e6-466a-8639-42626fbf3be9
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 19, 2022
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 | 144 |
2 | A medical device with a moderate to high risk that requires special controls. | 183 |
U | Unclassified | 7 |