Duns Number:320249162
Device Description: MOSS XT Ti Pedicle Screw Ø12.0x100mm injection channel, blue, cannulated DL, polyaxial
Catalog Number
113-092-T100
Brand Name
NA
Version/Model Number
113-092-T100
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
-
Product Code
NKB
Product Code Name
Thoracolumbosacral pedicle screw system
Public Device Record Key
9ba62bf0-36bd-42e4-8376-0ba04f22e325
Public Version Date
September 24, 2021
Public Version Number
1
DI Record Publish Date
September 16, 2021
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 | 359 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |