Duns Number:174262477
Device Description: STRADI -TUBE TUMESCENT INFILTRATION TUBING
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
525-110
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 10, 2022
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
0c013cf5-7765-408d-9910-ac378fc39cf7
Public Version Date
February 11, 2022
Public Version Number
2
DI Record Publish Date
April 13, 2018
Package DI Number
M7525251105
Quantity per Package
10
Contains DI Package
M7525251100
Package Discontinue Date
February 10, 2022
Package Status
Not 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 |