Duns Number:006959555
Device Description: Antibacterial, Pure-Tone, Sterile Fabric Adhesive Bandages, all one size, 3/4 IN x 3 IN (1 Antibacterial, Pure-Tone, Sterile Fabric Adhesive Bandages, all one size, 3/4 IN x 3 IN (19 mm x 76 mm)
Catalog Number
4609944
Brand Name
meijer
Version/Model Number
760236292616
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
e012dede-8f9a-4738-be00-56cf1b6613e1
Public Version Date
October 19, 2021
Public Version Number
1
DI Record Publish Date
October 11, 2021
Package DI Number
10760236292613
Quantity per Package
72
Contains DI Package
00760236292616
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |