Duns Number:942377524
Device Description: The Modular Ulnar Head Head Trial is used to determine the proper implant head size by eva The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluating congurency and joint articulation.
Catalog Number
TRL-600-H160
Brand Name
Integra® First Choice®
Version/Model Number
TRL600H160
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
K112481
Product Code
KXE
Product Code Name
PROSTHESIS, WRIST, HEMI-, ULNAR
Public Device Record Key
26cfc6f8-a66e-4770-bfaf-8c50fef4c721
Public Version Date
December 11, 2020
Public Version Number
5
DI Record Publish Date
August 15, 2016
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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |