Duns Number:314101143
Device Description: EEG Trunk Cable, 4 channel, reusable, 2, 7 meter (8.8 ft) long, shielded for 9 lead EEG mo EEG Trunk Cable, 4 channel, reusable, 2, 7 meter (8.8 ft) long, shielded for 9 lead EEG monitoring. Use with 98980310561, 989803180521 or 989803180531 lead sets. The 4 channel trunk cable can also be used for 2 channels. In this case lead sets M1931A, M1932A, M1934A are recommended.
Catalog Number
989803180541
Brand Name
NA
Version/Model Number
EEG CBL 4CH Trunk Cable, 2.7m
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
ad8c601c-7f9f-42ca-b586-ee3fd9549708
Public Version Date
September 20, 2022
Public Version Number
5
DI Record Publish Date
December 27, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 209 |