Duns Number:062312574
Device Description: CVS Health Plantar Fasciitis Gel Arch Sleeves
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
894776
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 18, 2024
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"
-
For Single-Use
-
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
FMP
Product Code Name
Protector, Skin Pressure
Public Device Record Key
ee1b3963-db40-495e-b71f-9ac9444621dd
Public Version Date
June 26, 2020
Public Version Number
1
DI Record Publish Date
June 18, 2020
Package DI Number
50050428396082
Quantity per Package
84
Contains DI Package
00050428396087
Package Discontinue Date
June 18, 2024
Package Status
In Commercial Distribution
Package Type
Case Pack
| 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 |