Duns Number:961027315
Device Description: Drain Sponges 4 x 4in. (10.2 x 10.2cm)16-ply Woven 100 percent Cotton Pre-Slit. Sterile.S Drain Sponges 4 x 4in. (10.2 x 10.2cm)16-ply Woven 100 percent Cotton Pre-Slit. Sterile.Sterilized Using Ethylene Oxide. Single Use Only.Not Made with Natural Rubber Latex. Store in a Cool,Dry Place.
Catalog Number
C-DRS4416S
Brand Name
CARDINAL HEALTH
Version/Model Number
C-DRS4416S
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
eaec52f1-26f8-4822-bd8b-fa216dbb94dc
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
June 19, 2019
Package DI Number
20885380130905
Quantity per Package
25
Contains DI Package
10885380130908
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |