Duns Number:063997360
Device Description: Advanced Antibacterial Clear Waterproof Strong Strips; XL Adhesive Bandages; Triple Pad Te Advanced Antibacterial Clear Waterproof Strong Strips; XL Adhesive Bandages; Triple Pad Technology; Helps Prevent Infection; 3x Absorbent Pad; Pain Free Film; Extra Large; 2 IN. x 4 IN.; Antibacterial Agent Benzalkonium Chloride 0.1%
Catalog Number
4902474
Brand Name
LEADER
Version/Model Number
4902474
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 19, 2022
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
69ac7a80-692a-4faf-8503-518822fddeaf
Public Version Date
October 20, 2022
Public Version Number
4
DI Record Publish Date
April 18, 2019
Package DI Number
50096295124038
Quantity per Package
24
Contains DI Package
00096295124033
Package Discontinue Date
October 19, 2022
Package Status
Not 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 |