Duns Number:961027315
Device Description: STERILE CAST PADDING KIT
Catalog Number
23626-540
Brand Name
CARDINAL HEALTH
Version/Model Number
23626-540
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ITG
Product Code Name
BANDAGE, CAST
Public Device Record Key
bf364a06-7617-4aaa-92cb-f8e7f9e9d1ed
Public Version Date
December 31, 2020
Public Version Number
3
DI Record Publish Date
October 01, 2018
Package DI Number
50885425500640
Quantity per Package
36
Contains DI Package
10885425500642
Package Discontinue Date
December 31, 2020
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 |