Duns Number:933200842
Device Description: The ATLAS TPSS Cable is an adapter that allows signals from an electrode interface to be r The ATLAS TPSS Cable is an adapter that allows signals from an electrode interface to be recorded by not only the ATLAS Neurophysiology System by Neuralynx, Inc. but also other neurophysiology recording systems with touch proof connectors. The ATLAS TPSS Cable shares the outputs from the electrode interface and splits them to both systems to be digitized.
Catalog Number
31-0602-0027
Brand Name
ATLAS TPSS Cable
Version/Model Number
ATLAS TPSS Cable
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
32dc47ea-9241-420f-8068-16cbaf60f7bf
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 15, 2016
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 |