Duns Number:023904428
Device Description: DRESSING, HYDROCOLLOID FOAM BACK 4”x4"
Catalog Number
-
Brand Name
McKesson
Version/Model Number
1889
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
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
01fc75d1-1d86-44e0-88b2-f1b46cc259e4
Public Version Date
August 08, 2022
Public Version Number
1
DI Record Publish Date
July 29, 2022
Package DI Number
20612479193011
Quantity per Package
10
Contains DI Package
10612479193007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |