Duns Number:314101143
Device Description: EEG Lead Set with 9 individual color coded leads for use on neonatal and pediatric patient EEG Lead Set with 9 individual color coded leads for use on neonatal and pediatric patients. Lead wires comes with DIN connector on one end and hard mounted EEG silver clip electrodes on the other end. Individual leads are hold in place with a lead organizer. Silver clip diameter = 6 mm, 80 cm (31.5 in) long leads. Use with trunk cable 989803180541and conductive paste M1937A.
Catalog Number
989803180531
Brand Name
NA
Version/Model Number
EEG CBL Lead Set Mini for 9 Elec.
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
82abda24-4b23-452e-9bdf-a986fcbf6365
Public Version Date
September 21, 2022
Public Version Number
5
DI Record Publish Date
November 03, 2017
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 |