Duns Number:080948525
Device Description: Disposable snap that snaps onto a Jamshidi for instrument tracking.Instrument Tracker . Disposable snap that snaps onto a Jamshidi for instrument tracking.Instrument Tracker .125 IN(previously known as Snap 2 or 12)
Catalog Number
TX-3-3038
Brand Name
TrackX
Version/Model Number
T SNAP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 18, 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
K173736,K173736
Product Code
OWB
Product Code Name
Interventional Fluoroscopic X-Ray System
Public Device Record Key
13b72611-dff6-4a0d-a45a-14e63c362911
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
August 29, 2018
Package DI Number
00860099000875
Quantity per Package
5
Contains DI Package
00860099000813
Package Discontinue Date
February 18, 2022
Package Status
Not in Commercial Distribution
Package Type
Shelf Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |