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
31-0202-0001
Brand Name
High Density Tether
Version/Model Number
High Density 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
179f531e-a088-48b5-8919-428f9f6592c7
Public Version Date
November 15, 2021
Public Version Number
1
DI Record Publish Date
November 05, 2021
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 |