Duns Number:116956644
Device Description: Antibacterial Strong Strips Adhesive Bandages, all one size, 1 IN x 3 1/4 IN (25 mm x 82 m Antibacterial Strong Strips Adhesive Bandages, all one size, 1 IN x 3 1/4 IN (25 mm x 82 mm)
Catalog Number
-
Brand Name
Health Mart
Version/Model Number
052569133293
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
5413b96c-a5bf-4036-a381-40d141af18e8
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
July 31, 2020
Package DI Number
20052569133297
Quantity per Package
72
Contains DI Package
00052569133293
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |