Duns Number:174262477
Device Description: Lidocaine Supplement Kit
Catalog Number
-
Brand Name
Stradis Medical, LLC
Version/Model Number
VA-201
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"
Yes
For Single-Use
Yes
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
-
Product Code Name
-
Public Device Record Key
bdd06c5e-3ce3-4924-8cc9-a53a6bf4ab88
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
October 25, 2018
Package DI Number
M752VA2015
Quantity per Package
100
Contains DI Package
M752VA2011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
outer box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1431 |
| U | Unclassified | 10 |