Duns Number:062312574
Device Description: Hydrocolloid Gel Adhesive Pads, 3.94 IN x 3.94 IN (100 mm x 100 mm)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
245031
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
72f18a4e-4934-4359-9bdf-817563234786
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
September 07, 2020
Package DI Number
20050428593114
Quantity per Package
24
Contains DI Package
00050428593110
Package Discontinue Date
-
Package Status
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 |