Duns Number:092364462
Device Description: Kit: Take Home Total Joints 20/Cs
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
75204
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OXQ
Product Code Name
Dressing change tray
Public Device Record Key
9e34c486-d445-4aeb-885f-9c75922da75c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 20, 2016
Package DI Number
20809160023911
Quantity per Package
20
Contains DI Package
10809160023914
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 548 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
| U | Unclassified | 1 |