Duns Number:961027315
Device Description: COTTON ROLL 1LB STERILE
Catalog Number
C-RGS1LB
Brand Name
CARDINAL HEALTH
Version/Model Number
C-RGS1LB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 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
EFN
Product Code Name
COTTON, ROLL
Public Device Record Key
c5efdb39-970b-4893-b582-9abe33ffd8de
Public Version Date
March 01, 2022
Public Version Number
4
DI Record Publish Date
July 11, 2019
Package DI Number
50885380054165
Quantity per Package
10
Contains DI Package
10885380054167
Package Discontinue Date
March 01, 2022
Package Status
Not 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 |