Duns Number:314101143
Device Description: EEG Lead Set with 9 individual color coded leads. Lead wires come with DIN connector on on EEG Lead Set with 9 individual color coded leads. Lead wires come with DIN connector on one end and hard mounted mini cup (grabber style) to connect to any generic snap style electrode on the other end. Wires are hold in place with a lead organizer. 80 cm (31.5 in) long leads.Use with trunk cable 989803180541.
Catalog Number
989803180521
Brand Name
NA
Version/Model Number
EEG CBL Lead Set Neo/Pedi 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
2f4ddf80-cd22-44d3-8e65-a102ea4ba660
Public Version Date
September 22, 2022
Public Version Number
5
DI Record Publish Date
December 05, 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 |