Duns Number:062312574
Device Description: Flexible Fabric Antibacterial Bandages, assorted sizes, 1 3/4 IN x 2 IN (44 mm x 50 mm), 1 Flexible Fabric Antibacterial Bandages, assorted sizes, 1 3/4 IN x 2 IN (44 mm x 50 mm), 1 1/2 IN x 3 IN (38 mm x 76 mm)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
875952
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
dca84549-3a73-4372-9346-9a365f0520f4
Public Version Date
January 13, 2021
Public Version Number
1
DI Record Publish Date
January 05, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |