Duns Number:092519016
Device Description: THC COOH HYDROLYSIS QC
Catalog Number
91804
Brand Name
THC COOH HYDROLYSIS QC
Version/Model Number
91804
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
e89eadcf-1dfb-47a5-bee5-3b23634b7996
Public Version Date
August 03, 2020
Public Version Number
1
DI Record Publish Date
July 24, 2020
Package DI Number
B800918045
Quantity per Package
5
Contains DI Package
B800918040
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 |