Duns Number:080948525
Device Description: The device consists of a sterile Snap that includes reflective features that facilitate im The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
Catalog Number
900-3TX
Brand Name
TrackX
Version/Model Number
ATEC Lateral Kit 2.0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 26, 2022
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
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
3cd3e255-0169-4e2c-a3af-f1ebed97a8e8
Public Version Date
July 07, 2022
Public Version Number
2
DI Record Publish Date
April 06, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |