Duns Number:656700556
Device Description: U2 Total Knee System
Catalog Number
9403-5323
Brand Name
Tibial baseplate wrench, M
Version/Model Number
9403-5323
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"
-
For Single-Use
-
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
HXC
Product Code Name
Wrench
Public Device Record Key
787b6b6c-6254-4adf-8d51-1cea7419d483
Public Version Date
August 23, 2018
Public Version Number
1
DI Record Publish Date
July 23, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1150 |
2 | A medical device with a moderate to high risk that requires special controls. | 4885 |