Duns Number:062312574
Device Description: Heavy Duty Fabric, Antibacterial Bandages, all one size, 1 IN x 3 1/4 IN (25 mm x 82 mm)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
875957
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 25, 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
dbde21be-3152-4314-bdea-6b6c59c569d3
Public Version Date
August 17, 2021
Public Version Number
3
DI Record Publish Date
February 28, 2020
Package DI Number
20050428264717
Quantity per Package
72
Contains DI Package
00050428264713
Package Discontinue Date
May 25, 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |