Duns Number:128990418
Device Description: Amazon Basics Flexible Fabric Adhesive Bandages, One Size, 100 Count
Catalog Number
B09KCNG6SK
Brand Name
Amazon Basics
Version/Model Number
B09KCNG6SK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 28, 2022
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
e7a7267d-08ee-4aab-bda4-e566dc610b79
Public Version Date
March 29, 2022
Public Version Number
2
DI Record Publish Date
October 27, 2021
Package DI Number
10195515027011
Quantity per Package
12
Contains DI Package
00195515027014
Package Discontinue Date
March 28, 2022
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |