Duns Number:062312574
Device Description: Emulsion Non-Stick Pads, all one size, 3 IN x 3 IN (76 mm x 76 mm)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
894119
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 27, 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
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
ee806bd5-efb8-4745-b879-99591ebeb02a
Public Version Date
April 05, 2022
Public Version Number
2
DI Record Publish Date
January 27, 2020
Package DI Number
20050428399280
Quantity per Package
72
Contains DI Package
00050428399286
Package Discontinue Date
July 27, 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 |