Duns Number:961027315
Device Description: CENTENNIAL TOTAL KNEE PK
Catalog Number
SOP73KTC10
Brand Name
CARDINAL HEALTH
Version/Model Number
SOP73KTC10
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
OJH
Product Code Name
Orthopedic tray
Public Device Record Key
bb9c11f2-1408-4dde-9543-61a4b84e6063
Public Version Date
August 19, 2020
Public Version Number
1
DI Record Publish Date
August 11, 2020
Package DI Number
50888439872383
Quantity per Package
1
Contains DI Package
10888439872385
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 |