Duns Number:942377524
Device Description: The Head Sizing Plate is used to find the base width, along with the need for a concentric The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Catalog Number
HSP-0923-070-007
Brand Name
Titan™
Version/Model Number
HSP-0923-070-007
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
HWT
Product Code Name
TEMPLATE
Public Device Record Key
a3a07bf8-ca62-4121-9511-42ab05f834ee
Public Version Date
December 29, 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 |