Primary Device ID | G134NCCPXS1 |
NIH Device Record Key | 02d81359-50a6-4da7-8713-12a9821717d2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NeuroCatch EEG Cap |
Version Model Number | 2.0 |
Catalog Number | NCCPXS |
Company DUNS | 203694427 |
Company Name | NeuroCatch Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | G134NCCPXS1 [Primary] |
PTY | Computerized Cognitive Assessment Aid, Exempt |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-09 |
Device Publish Date | 2024-12-01 |
G134NCCPS1 | NeuroCatch EEG Cap, size Small for use with the NeuroCatch Platform system |
G134NCCPM1 | NeuroCatch EEG Cap, size Medium for use with the NeuroCatch Platform system |
G134NCCPL1 | NeuroCatch EEG Cap, size Large for use with the NeuroCatch Platform system |
G134NCCPXS1 | NeuroCatch EEG Cap, size extra small for use with the NeuroCatch Platform System |