Duns Number:933200842
Device Description: The ATLAS-HS-36-CHET-D18 is a clinical headstage that allows two 18 contact DIXI electrode The ATLAS-HS-36-CHET-D18 is a clinical headstage that allows two 18 contact DIXI electrode connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-D18 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.
Catalog Number
31-0601-0082
Brand Name
ATLAS-HS-36-CHET-D18
Version/Model Number
ATLAS-HS-36-CHET-D18
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
GWL
Product Code Name
Amplifier, Physiological Signal
Public Device Record Key
2f950c21-ce05-4c39-a3da-5f3008d6b317
Public Version Date
December 05, 2019
Public Version Number
1
DI Record Publish Date
November 27, 2019
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 |