Duns Number:961027315
Device Description: Premium Gauze Sponges 4 x 4in. (10.2 x 10.2cm)Woven 100 percent Cotton. Non sterile. Singl Premium Gauze Sponges 4 x 4in. (10.2 x 10.2cm)Woven 100 percent Cotton. Non sterile. Single Use Only. Not Made with Natural Rubber Latex. Store in a Cool, Dry Place.
Catalog Number
BNS-3432
Brand Name
CARDINAL HEALTH
Version/Model Number
BNS-3432
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2023
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
537c5a83-695d-4542-a5fe-ab5db4cac8fc
Public Version Date
February 24, 2022
Public Version Number
2
DI Record Publish Date
June 19, 2019
Package DI Number
50885380053076
Quantity per Package
10
Contains DI Package
20885380053075
Package Discontinue Date
December 31, 2023
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |