Duns Number:092519016
Device Description: DRUGS OF ABUSE +50%
Catalog Number
-
Brand Name
DRUGS OF ABUSE +50%
Version/Model Number
DAU SCR +50 SAFE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LAS
Product Code Name
Drug Specific Control Materials
Public Device Record Key
bf6d3976-3619-46ad-80ca-3e4dd2c9b87a
Public Version Date
August 22, 2022
Public Version Number
1
DI Record Publish Date
August 12, 2022
Package DI Number
B80004644000011
Quantity per Package
4
Contains DI Package
B80004644000010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 113 |