Duns Number:830350380
Device Description: TSR TT T-BOLT 14MM 5.5 TI
Catalog Number
-
Brand Name
GDLH® Posterior Spinal System
Version/Model Number
X0196-034
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 12, 2018
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
K143375
Product Code
HBE
Product Code Name
DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
Public Device Record Key
fac50d43-474b-42d3-8c78-685c0f9f46f5
Public Version Date
January 25, 2019
Public Version Number
4
DI Record Publish Date
March 16, 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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |