Duns Number:078766464
Device Description: The NeuralBot procedural set contains the following single use items; probe pod covers, he The NeuralBot procedural set contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.
Catalog Number
NA-DSP2
Brand Name
NeuralBot Procedural Set (Single Use)
Version/Model Number
1.x
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 26, 2018
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
K180455
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
c000d675-321a-4bdb-b446-a50e56e173a6
Public Version Date
August 19, 2022
Public Version Number
4
DI Record Publish Date
July 26, 2018
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. | 18 |