Duns Number:152793493
Device Description: Clear Adhesive Bandages, 7/8 in.
Catalog Number
017276233742
Brand Name
ALL-HEALTH Adhesive Bandages
Version/Model Number
017276233742
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 24, 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
65c21402-aced-453c-bdd1-8697880064a0
Public Version Date
September 15, 2021
Public Version Number
4
DI Record Publish Date
March 29, 2019
Package DI Number
20017276233746
Quantity per Package
72
Contains DI Package
00017276233742
Package Discontinue Date
December 24, 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 | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |