Duns Number:961027315
Device Description: SHOECOVER DURA FIT XL
Catalog Number
4854
Brand Name
CARDINAL HEALTH
Version/Model Number
4854
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
FXP
Product Code Name
COVER, SHOE, OPERATING-ROOM
Public Device Record Key
acc8dcd8-3ea4-451a-bb73-1f9a47125bf1
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
November 14, 2018
Package DI Number
50885380019829
Quantity per Package
4
Contains DI Package
20885380019828
Package Discontinue Date
-
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 |