Duns Number:961027315
Device Description: Super Fluff Sponges 4 x 4in. (10.2 x 10.2cm)12-Ply. Sterile. Sterilized Using EthyleneOx Super Fluff Sponges 4 x 4in. (10.2 x 10.2cm)12-Ply. Sterile. Sterilized Using EthyleneOxide. Single Use Only. Not Made with NaturalRubber Latex. Store in a Cool, Dry Place.
Catalog Number
C-SUS4412S
Brand Name
CARDINAL HEALTH
Version/Model Number
C-SUS4412S
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
NAB
Product Code Name
Gauze / sponge,nonresorbable for external use
Public Device Record Key
b6a0cae8-6f76-429d-b73d-2c4ee26be9d8
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
June 19, 2019
Package DI Number
50885380133709
Quantity per Package
24
Contains DI Package
30885380133705
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 | 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 |