Duns Number:062312574
Device Description: Sheer Spot Bandages, all one size: 7/8 IN (22 mm)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
955443
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 03, 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
0c7bf3a2-739a-4e27-b358-402d9664a072
Public Version Date
August 17, 2021
Public Version Number
4
DI Record Publish Date
December 23, 2019
Package DI Number
20050428266933
Quantity per Package
12
Contains DI Package
00050428266939
Package Discontinue Date
May 03, 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 |