Duns Number:933200842
Device Description: The ATLAS-CHET-36-TETHER is a connection between the ATLAS-HS-36-CHET-X headstage and the The ATLAS-CHET-36-TETHER is a connection between the ATLAS-HS-36-CHET-X headstage and the ATLAS Neurophysiology System; Note X denotes the type of electrode connection for the CHET, while the TETHER is compatible with multiple CHET-X designs.
Catalog Number
31-0613-0026
Brand Name
ATLAS-HS-36-CHET-TETHER
Version/Model Number
ATLAS-HS-36-CHET-TETHER
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
00a1427e-f125-4bec-bf2b-46707f557a0e
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 |