Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
59546B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 09, 2022
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)
Yes
Over the Counter (OTC)
-
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
ac7b5dc2-0821-4248-8dde-8b72bca5e310
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
20809160022730
Quantity per Package
20
Contains DI Package
10809160022733
Package Discontinue Date
June 09, 2022
Package Status
Not 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 |