Duns Number:062312574
Device Description: Wound Closures: 1/4 IN x 4 IN (6.35 mm x 101 mm)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
955729
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
FPX
Product Code Name
Strip, Adhesive, Closure, Skin
Public Device Record Key
1d231dbc-cc45-4fdf-bcd5-00097f9374c7
Public Version Date
March 09, 2020
Public Version Number
1
DI Record Publish Date
February 28, 2020
Package DI Number
20050428288461
Quantity per Package
36
Contains DI Package
00050428288467
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 |