Duns Number:043537671
Device Description: Dressing Change Tray
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
IM1256
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
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
MCY
Product Code Name
Wound Dressing Kit
Public Device Record Key
52611eda-46df-4a64-8032-66a0b3042c75
Public Version Date
March 25, 2020
Public Version Number
2
DI Record Publish Date
May 23, 2018
Package DI Number
M752IM12665
Quantity per Package
30
Contains DI Package
M752IM12560
Package Discontinue Date
March 23, 2020
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |