Duns Number:152793493
Device Description: Antibacterial Bandages, 3/4 IN x 3 IN (19 mm x 76 mm)
Catalog Number
-
Brand Name
Emoji
Version/Model Number
017276238341
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 2021
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
28166ede-2b62-4abe-97c3-04af41ec42d6
Public Version Date
August 04, 2022
Public Version Number
2
DI Record Publish Date
June 21, 2021
Package DI Number
20017276238345
Quantity per Package
24
Contains DI Package
00017276238341
Package Discontinue Date
June 21, 2021
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 | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |