Duns Number:290318455
Device Description: A mobile workstation composed by a central unit with ultrasound beamformer, a tactile sc A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart,Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
Catalog Number
-
Brand Name
TRINITY
Version/Model Number
KURO3000-2
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
-
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
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
e855f1be-b0a7-4cc9-af58-c87ffdf8d065
Public Version Date
November 18, 2019
Public Version Number
1
DI Record Publish Date
November 08, 2019
Package DI Number
03665134000547
Quantity per Package
1
Contains DI Package
03665134000035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Flight case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |