Duns Number:985065024
Device Description: EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The device is single use only. This new DI is a new packaging format. The old number was a tray with a peel off lid. This DI is the "Clamshell" in a pouch packaging
Catalog Number
-
Brand Name
neon8
Version/Model Number
TF04
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
Yes
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
K151576,K151576,K151576
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
80df5894-6387-475d-ab75-76b425f8aee7
Public Version Date
March 25, 2022
Public Version Number
2
DI Record Publish Date
January 16, 2022
Package DI Number
05391530950084
Quantity per Package
5
Contains DI Package
05391530950077
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |