Duns Number:961027315
Device Description: STERILE SHOECOVER PACK
Catalog Number
SID15SCFCB
Brand Name
CARDINAL HEALTH
Version/Model Number
SID15SCFCB
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)
Yes
Over the Counter (OTC)
-
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
930075a9-0da0-40ea-834f-a7dd042aaa1a
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
August 09, 2016
Package DI Number
50885425412790
Quantity per Package
40
Contains DI Package
10885425412792
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 |