Duns Number:023904428
Device Description: Dressing Change Tray
Catalog Number
-
Brand Name
McKesson
Version/Model Number
7598
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)
-
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
6587b53a-43f6-457c-9ff1-a727177b8de2
Public Version Date
February 24, 2020
Public Version Number
1
DI Record Publish Date
February 14, 2020
Package DI Number
40612479251937
Quantity per Package
20
Contains DI Package
10612479251929
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |