Duns Number:933200842
Device Description: The ATLAS-HS-36-CHET-IDC10 is a clinical headstage that allows four X 3M 10 Pin Receptacl The ATLAS-HS-36-CHET-IDC10 is a clinical headstage that allows four X 3M 10 Pin Receptacle Connector (e.g. 8510-4500PL) connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-IDC10 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
31-0601-0087
Brand Name
ATLAS-HS-36-CHET-IDC10
Version/Model Number
ATLAS-HS-36-CHET-IDC10
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
17e500b7-8582-434b-a567-2bac2ddcbc8d
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 |