Duns Number:961027315
Device Description: ANKLE-TOP SHOE COVER XL
Catalog Number
8358A
Brand Name
CARDINAL HEALTH
Version/Model Number
8358A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 04, 2024
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
73f9056b-d196-46f7-bdb0-caa6aa38255b
Public Version Date
December 03, 2021
Public Version Number
3
DI Record Publish Date
November 14, 2018
Package DI Number
50885380144750
Quantity per Package
4
Contains DI Package
20885380144759
Package Discontinue Date
November 04, 2024
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 |