Duns Number:062312574
Device Description: Sterile Gauze Pads, 12-ply design, 2 IN x 2 IN (5 cm x 5 cm)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
894101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 30, 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
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
a4aa4f63-83e6-4bb2-a988-c532d5c09985
Public Version Date
September 15, 2021
Public Version Number
4
DI Record Publish Date
August 24, 2020
Package DI Number
20050428341562
Quantity per Package
36
Contains DI Package
00050428341568
Package Discontinue Date
July 30, 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 |