Duns Number:961027315
Device Description: CSR Wrap 24" x 24", Disposable
Catalog Number
AT21324
Brand Name
CARDINAL HEALTH
Version/Model Number
AT21324
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 26, 2025
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
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
3ba45819-02a4-4734-a1fc-0a6015ee9803
Public Version Date
October 13, 2020
Public Version Number
5
DI Record Publish Date
September 19, 2016
Package DI Number
50885380136694
Quantity per Package
5
Contains DI Package
20885380136693
Package Discontinue Date
January 26, 2025
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 |