Duns Number:062312574
Device Description: Cushioned Comfort Wrap, 1 roll, 3 IN x 2.3 YDS (7.6 cm x 2.1 m)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
375786
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 26, 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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
85dcc016-af8a-4f4a-b123-adc632281ada
Public Version Date
December 08, 2021
Public Version Number
3
DI Record Publish Date
September 07, 2020
Package DI Number
20050428606586
Quantity per Package
72
Contains DI Package
00050428606582
Package Discontinue Date
March 26, 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 |