Duns Number:961027315
Device Description: Gauze Sponges 2 x 2in. (5.1 x 5.1cm)12-Ply Woven 100 percent Cotton Non Sterile.Single Us Gauze Sponges 2 x 2in. (5.1 x 5.1cm)12-Ply Woven 100 percent Cotton Non Sterile.Single Use Only. Not Made with Natural RubberLatex. Store in a Cool, Dry Place.
Catalog Number
C-NSG2212E
Brand Name
CARDINAL HEALTH
Version/Model Number
C-NSG2212E
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
bd6b6925-2d92-4741-b196-8c5af3855750
Public Version Date
February 24, 2022
Public Version Number
2
DI Record Publish Date
June 19, 2019
Package DI Number
50885380066618
Quantity per Package
40
Contains DI Package
20885380066617
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 |