Duns Number:023904428
Device Description: Adhesive Dressing McKesson 4 X 4 Inch NonWoven Gauze Square White NonSterile
Catalog Number
-
Brand Name
Mckesson
Version/Model Number
16-89244
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
b7dbfc08-4d65-4a93-bfeb-ce28821a5f9a
Public Version Date
August 13, 2020
Public Version Number
1
DI Record Publish Date
August 05, 2020
Package DI Number
40612479193190
Quantity per Package
4
Contains DI Package
20612479193189
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 |