Duns Number:152793493
Device Description: Flexible Fabric Adhesive Bandages, assorted sizes (5/8 in x 2 1/4 in; 3/4 in x 3 in; 1 in Flexible Fabric Adhesive Bandages, assorted sizes (5/8 in x 2 1/4 in; 3/4 in x 3 in; 1 in x 3 in)
Catalog Number
017276233711
Brand Name
ALL-HEALTH Adhesive Bandages
Version/Model Number
017276233711
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
0dd6f3dc-508e-4594-bf9e-a195aa0a1ff8
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
March 29, 2019
Package DI Number
20017276233715
Quantity per Package
72
Contains DI Package
00017276233711
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 | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |