Duns Number:058311945
Device Description: Trident II PSL Clusterhole HA Acetabular Shell 54E
Catalog Number
742-11-54E
Brand Name
TRIDENT II
Version/Model Number
742-11-54E
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
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
JDI
Product Code Name
Prosthesis, hip, semi-constrained, metal/polymer, cemented
Public Device Record Key
7f08c5a9-3c3a-4838-aa88-590daacd5a4a
Public Version Date
August 03, 2022
Public Version Number
4
DI Record Publish Date
February 12, 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 | 5091 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10216 |
| 3 | A medical device with high risk that requires premarket approval | 32 |