Duns Number:174262477
Device Description: Dressing Change Tray w/Grip-Lok
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
RXR-20451
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
c7263673-07c0-4648-9994-7516f5fe93ce
Public Version Date
September 06, 2018
Public Version Number
1
DI Record Publish Date
August 06, 2018
Package DI Number
M752RXR204515
Quantity per Package
24
Contains DI Package
M752RXR204510
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 | 1226 |
2 | A medical device with a moderate to high risk that requires special controls. | 1431 |
U | Unclassified | 10 |