Duns Number:933200842
Device Description: The ATLAS Patient Event Marker is an optional configuration of the ATLAS Neurophysiology S The ATLAS Patient Event Marker is an optional configuration of the ATLAS Neurophysiology System that allows the patient to mark an event in the Data Acquisition Software.
Catalog Number
Patient Event Marker
Brand Name
ATLAS Patient Event Marker
Version/Model Number
ATLAS Patient Event Marker
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
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
93ed18ea-1597-40fe-b5b0-2c9b749e7ac8
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
September 19, 2022
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. | 50 |