Duns Number:942377524
Device Description: Modular Radial Head MRH Trial, Ti, Sz. 22L
Catalog Number
TRL-351-22L
Brand Name
Integra®
Version/Model Number
TRL35122L
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
K032686
Product Code
KWI
Product Code Name
PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
Public Device Record Key
5ad78a99-cd5a-4cfc-8e07-ab7d5d6e7481
Public Version Date
August 27, 2020
Public Version Number
6
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 |