Duns Number:063997360
Device Description: Antibacterial Strong Strips Adhesive Bandages; Extra Large; 1 3/4 IN. x 4 IN.; Active Ingr Antibacterial Strong Strips Adhesive Bandages; Extra Large; 1 3/4 IN. x 4 IN.; Active Ingredient: Benzalkonium Chloride 0.1 Percent
Catalog Number
4903019
Brand Name
LEADER
Version/Model Number
4903019
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)
Yes
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
6b65ed07-824d-4c87-b4e7-1de9ba874223
Public Version Date
February 28, 2022
Public Version Number
3
DI Record Publish Date
April 18, 2019
Package DI Number
50096295124083
Quantity per Package
24
Contains DI Package
00096295124088
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |