Duns Number:961027315
Device Description: NONWOVEN SPONGE-PREMIUM 4X4 3PLY NS
Catalog Number
C-NWSD443
Brand Name
CARDINAL HEALTH
Version/Model Number
C-NWSD443
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
ffb4805b-39db-497e-9368-414b3dd3aff3
Public Version Date
June 09, 2021
Public Version Number
2
DI Record Publish Date
June 27, 2019
Package DI Number
50885380054363
Quantity per Package
10
Contains DI Package
20885380054362
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 |