Duns Number:023904428
Device Description: Wound Irrigation & Management Solution 16oz Septum Cap
Catalog Number
-
Brand Name
McKesson
Version/Model Number
186-6516
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
-
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
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
755283cb-dfac-4c81-b786-8a4f32734b27
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
March 22, 2019
Package DI Number
00612479232426
Quantity per Package
6
Contains DI Package
00612479232419
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 |