Duns Number:063997360
Device Description: Advanced Antibacterial Fabric Bandages; Helps Prevent Infection; Flexible Protection; Pain Advanced Antibacterial Fabric Bandages; Helps Prevent Infection; Flexible Protection; Pain Free Film; Kills Bacteria; 3x Absorbent; Triple Pad Technology; Active Ingredient Benzalkonium Chloride 0.1 Percent; All One Size 3/4 IN. x 3 IN.
Catalog Number
4902490
Brand Name
LEADER
Version/Model Number
4902490
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
4c66d198-6e2f-4813-aef2-4b809ce93274
Public Version Date
July 02, 2021
Public Version Number
3
DI Record Publish Date
April 18, 2019
Package DI Number
50096295124045
Quantity per Package
24
Contains DI Package
00096295124040
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 |