Duns Number:961027315
Device Description: -Premium Gauze Sponges-4 x 4 in (10.2 x 10.2 cm)-12-Ply -USP Type VII Gauze
Catalog Number
C-SG4412ZS
Brand Name
CARDINAL HEALTH
Version/Model Number
C-SG4412ZS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2022
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"
-
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
6cba5bdf-542e-4cd4-8f73-ca5709d6118b
Public Version Date
June 09, 2021
Public Version Number
3
DI Record Publish Date
September 11, 2019
Package DI Number
50885380133839
Quantity per Package
2
Contains DI Package
30885380133835
Package Discontinue Date
December 31, 2022
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 |