Primary Device ID | 00851113007161 |
NIH Device Record Key | 3a340da9-ab77-470a-b904-0251830cee7e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | X-Series, X8 |
Version Model Number | UN03-4004 |
Company DUNS | 969842715 |
Company Name | ADVANCED BRAIN MONITORING, INC. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
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 | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851113007161 [Primary] |
GWQ | Full-Montage Standard Electroencephalograph |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-24 |
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