Duns Number:043537671
Device Description: Explant Kit
Catalog Number
-
Brand Name
Stradis Medical, LLC
Version/Model Number
COTA-8138
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
5fb76eba-2b45-4243-b1d4-41bac07ad454
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
January 09, 2020
Package DI Number
M752COTA81385
Quantity per Package
20
Contains DI Package
M752COTA81381
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |