Duns Number:134614411
Device Description: Non-sterile marker with CIVCO general purpose sensor connection for use in MR and US envir Non-sterile marker with CIVCO general purpose sensor connection for use in MR and US environments
Catalog Number
610-1306
Brand Name
omniTRAX Active Patient Tracker
Version/Model Number
610-1306
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K143396,K143396
Product Code
IYO
Product Code Name
System, imaging, pulsed echo, ultrasonic
Public Device Record Key
0302514c-028b-46ad-b344-097a76583ee9
Public Version Date
September 06, 2021
Public Version Number
4
DI Record Publish Date
August 22, 2017
Package DI Number
00841436103121
Quantity per Package
12
Contains DI Package
10841436103128
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |