Duns Number:942377524
Device Description: Titan™ Total Shoulder SystemThe cemented long stem reamer is used to compress and/or remov Titan™ Total Shoulder SystemThe cemented long stem reamer is used to compress and/or remove bone to create a cavity of proper shape and size.
Catalog Number
RMR-0950-025-14125
Brand Name
Titan™
Version/Model Number
R95002514125
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
HTO
Product Code Name
REAMER
Public Device Record Key
319dc7cc-e9a6-4719-ae1c-438498ec6fa6
Public Version Date
December 29, 2020
Public Version Number
4
DI Record Publish Date
August 30, 2017
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 |