Duns Number:063997360
Device Description: Advanced Antibacterial Fabric Bandages; First Aid Antiseptic; Helps Prevent Infections; Pa Advanced Antibacterial Fabric Bandages; First Aid Antiseptic; Helps Prevent Infections; Pain Free Film; Kills Bacteria; 3X Absorbent Pad; Active Ingredient Benzalkonium Chloride 0.1%; All One Size 3/4 IN. x 3 IN.
Catalog Number
4935474
Brand Name
LEADER
Version/Model Number
4935474
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
a55953f0-cf4c-41ff-8495-efaa5437964c
Public Version Date
July 02, 2021
Public Version Number
3
DI Record Publish Date
April 18, 2019
Package DI Number
50096295125547
Quantity per Package
72
Contains DI Package
00096295125542
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 |