Duns Number:961027315
Device Description: KIT, ARTHROSCOPY KNEE, ALAMOGO
Catalog Number
PO54KANSO
Brand Name
CARDINAL HEALTH
Version/Model Number
PO54KANSO
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
e5d23159-adc3-49af-95ab-4ecfd91bc45c
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 08, 2019
Package DI Number
50888439284841
Quantity per Package
1
Contains DI Package
10888439284843
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 |