Duns Number:068331990
Device Description: Emoji Adhesive Bandages, sterile, 3/4 IN x 3 IN (19 mm x 76 mm)
Catalog Number
-
Brand Name
DGHealth
Version/Model Number
017276234831
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 07, 2020
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
4fe14c72-ebd5-41b7-8e9b-a01bb6ddddb4
Public Version Date
August 16, 2021
Public Version Number
2
DI Record Publish Date
September 07, 2020
Package DI Number
20017276234835
Quantity per Package
72
Contains DI Package
00017276234831
Package Discontinue Date
September 03, 2020
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |
| U | Unclassified | 1 |