Duns Number:043537671
Device Description: DRESSING CHANGE TRAY W/CHLOR ONE-STEP, TEGADERM, STATLOCK AND DRESSING
Catalog Number
-
Brand Name
Stradis Medical, LLC
Version/Model Number
RWM-69K-TA01
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
MCY
Product Code Name
Wound Dressing Kit
Public Device Record Key
36774759-8856-41a9-b6d5-2757cb06ac95
Public Version Date
October 08, 2021
Public Version Number
1
DI Record Publish Date
September 30, 2021
Package DI Number
M752RWM69KTA015
Quantity per Package
40
Contains DI Package
M752RWM69KTA010
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 |