Duns Number:942377524
Device Description: Titan™ Reverse Shoulder SystemGlenosphere ImpactorThe Glenosphere Impactor is used to prop Titan™ Reverse Shoulder SystemGlenosphere ImpactorThe Glenosphere Impactor is used to properly fit the implant and/or trial into the prepared cavity.
Catalog Number
IMP-0960-066-01
Brand Name
Titan™
Version/Model Number
IMP096006601
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
HWA
Product Code Name
IMPACTOR
Public Device Record Key
9182cbd4-11b1-41d7-9c05-4ad7ab82a8e9
Public Version Date
November 06, 2020
Public Version Number
3
DI Record Publish Date
September 05, 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 |