NeuroProbe 366-009080-00
GUDID 07290016450521
ALPHA OMEGA ENGINEERING CO. LTD.
Depth electrode| Primary Device ID | 07290016450521 |
| NIH Device Record Key | 3cc943bf-13c4-431e-a052-96e42563ad36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuroProbe |
| Version Model Number | MF-Shielded |
| Catalog Number | 366-009080-00 |
| Company DUNS | 531856466 |
| Company Name | ALPHA OMEGA ENGINEERING CO. LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8779196288 |
| m.andrea@alphaomega-eng.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016450521 [Primary] |
| GS1 | 17290016450528 [Package] Package: carton [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052527
FDA Product Code
| GZL | Electrode, Depth |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290016450521]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-22 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [NeuroProbe]
Trademark Results [NeuroProbe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROPROBE 73139404 1114455 Dead/Expired |
ELMED INCORPORATED 1977-08-30 |
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