Duns Number:174262477
Device Description: Dressing Change Tray W/Chloraprep One Step
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
MC-3513CL
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
25b4bcea-e8b5-4106-8076-5196011082ee
Public Version Date
July 16, 2018
Public Version Number
1
DI Record Publish Date
June 15, 2018
Package DI Number
M752MC3513CL5
Quantity per Package
30
Contains DI Package
M752MC3513CL0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
outer package
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 |