Duns Number:942377524
Device Description: RSS 4.5mm Star Screw and Cap; 45mm Length
Catalog Number
SCW-0961-046-45
Brand Name
Titan™
Version/Model Number
SCW-0961-046-45
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
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
K181999
Product Code
PHX
Product Code Name
shoulder prosthesis, reverse configuration
Public Device Record Key
edcb3950-80aa-438a-a1ac-6ded47c8d7aa
Public Version Date
December 06, 2018
Public Version Number
1
DI Record Publish Date
November 05, 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 | 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 |