Duns Number:063997360
Device Description: Antibacterial Plastic Adhesive Bandages; Helps Prevent Infection; Everyday Protection; Hig Antibacterial Plastic Adhesive Bandages; Helps Prevent Infection; Everyday Protection; Highly Absorbent; Non-Stick Pad; Long Lasting; All One Size 3/4 IN. x 3 IN.; Active Ingredient Benzalkonium Chloride 0.1%
Catalog Number
4901914
Brand Name
LEADER
Version/Model Number
4901914
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
857931e5-506d-4568-8eec-d1119c140353
Public Version Date
July 02, 2021
Public Version Number
3
DI Record Publish Date
April 18, 2019
Package DI Number
50096295123918
Quantity per Package
24
Contains DI Package
00096295123913
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 |