Duns Number:933200842
Device Description: The ATLAS-HS-36-CHET-A9 is a clinical headstage that allows four X 9 contact Adtech electr The ATLAS-HS-36-CHET-A9 is a clinical headstage that allows four X 9 contact Adtech electrode connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-A9 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
31-0601-0086
Brand Name
ATLAS-HS-36-CHET-A9
Version/Model Number
ATLAS-HS-36-CHET-A9
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
295ec203-dba3-4bf9-914f-816442bc5a89
Public Version Date
April 15, 2020
Public Version Number
1
DI Record Publish Date
April 07, 2020
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 |