Duns Number:942377524
Device Description: Integra® Ti6®The TS-Series depth gauge for 2.0/2.5 mm screws is a tool used to measure th Integra® Ti6®The TS-Series depth gauge for 2.0/2.5 mm screws is a tool used to measure the depth of a drilled hole.
Catalog Number
FS2030
Brand Name
Ti6® Internal Fixation System
Version/Model Number
FS2030
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
HTJ
Product Code Name
GAUGE, DEPTH
Public Device Record Key
20141d6d-22f5-48e6-a104-ab1f27c4d1d3
Public Version Date
December 07, 2018
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 |