Duns Number:023904428
Device Description: Foam, PHMB ADH w/ Border Sacral
Catalog Number
-
Brand Name
McKesson
Version/Model Number
4977
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181197,K181197,K181197
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
14a763e3-e79e-488c-8c58-02891748c5fe
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 12, 2019
Package DI Number
00612479243415
Quantity per Package
10
Contains DI Package
00612479243408
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 |