Duns Number:933200842
Device Description: The High Density Tether is a flexible cable to connect the High Density Junction Box to th The High Density Tether is a flexible cable to connect the High Density Junction Box to the ATLAS Neurophysiology System. The High Density Tether is a component of the ATLAS Neurophysiology System.
Catalog Number
31-0202-0003
Brand Name
High Density Tether 2m
Version/Model Number
2m
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
41f56246-7d0f-4481-8b90-a1daa46ce5ee
Public Version Date
January 28, 2022
Public Version Number
1
DI Record Publish Date
January 20, 2022
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 |