Duns Number:933200842
Device Description: The ATLAS TOPHAT Adapter cable allows signals from a Micromed JB TOPHAT electrode interfac The ATLAS TOPHAT Adapter cable allows signals from a Micromed JB TOPHAT electrode interface to be recorded by the ATLAS Neurophysiology System.
Catalog Number
31-0602-0010
Brand Name
ATLAS TOPHAT Adapter Cable
Version/Model Number
ATLAS TOPHAT Adapter Cable
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 10, 2021
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
6e3a5881-2f37-445a-a44b-f5a5d8370350
Public Version Date
August 11, 2021
Public Version Number
2
DI Record Publish Date
February 28, 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 |