| Primary Device ID | 07290016450019 |
| NIH Device Record Key | 3298ed52-4e81-4f6f-aa21-8646f2962245 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuroSmart MER Headstage |
| Version Model Number | NeuroSmart MER Headstage |
| Company DUNS | 531856466 |
| Company Name | ALPHA OMEGA ENGINEERING CO. LTD. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016450019 [Primary] |
| GZL | Electrode, Depth |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
[07290016450019]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-08 |
| Device Publish Date | 2023-12-30 |
| 07290114062374 | NeuroSmart MER Headstage |
| 07290016450019 | NeuroSmart MER Headstage |