| Primary Device ID | 07290014954694 |
| NIH Device Record Key | 80030716-db50-4d5f-8071-1b03b9e85e4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cannula |
| Version Model Number | Standard |
| Catalog Number | STR-020121-00 |
| 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 |
| Phone | 8779196288 |
| m.andrea@alphaomega-eng.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290014954694 [Primary] |
| GS1 | 17290014954691 [Package] Package: carton [10 Units] In Commercial Distribution |
| GZL | Electrode, Depth |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-22 |
| Device Publish Date | 2016-09-24 |
| 07290016450828 | insertion tube Array electrode |
| 07290016450804 | Insertion Tube Set 15mm above |
| 07290016450798 | Insertion Tube Set 20mm above |
| 07290016450781 | Insertion Tube Set 40mm above |
| 07290016450774 | Lead Insertion Tube |
| 07290016450767 | Extractor |
| 07290016450750 | Stylet without Cannula |
| 07290016450743 | Tapered |
| 17290016450733 | Tapered |
| 07290016450729 | Standard Without Stylet |
| 07290016450712 | Standard |
| 07290016450705 | Standard |
| 07290016450699 | Standard |
| 07290016450682 | Standard |
| 07290016450675 | Standard |
| 07290016450668 | Standard |
| 07290016450651 | Standard |
| 07290016450644 | Standard |
| 07290016450637 | Standard |
| 17290014954905 | Standard |
| 17290014954899 | Standard |
| 07290014954823 | Array electrode insertion tube |
| 07290014954809 | Insertion Tube Set 15mm above |
| 07290014954793 | Insertion Tube Set 20mm above |
| 07290014954762 | Extractor |
| 07290014954755 | Stylet |
| 07290014954748 | Tapered |
| 07290014954731 | Tapered |
| 07290014954717 | Standard |
| 07290014954700 | Standard |
| 07290014954694 | Standard |
| 07290014954687 | Standard |
| 07290014954670 | Standard |
| 07290014954663 | Standard |
| 07290014954656 | Standard |
| 07290014954649 | Standard |
| 07290014954632 | Standard |
| 17290114060407 | Sterile Nexframe/Starfix Stainless Steel Guide Tube (cannula) and Stylet |
| 07290114061094 | Standard |
| 17290114061039 | Standard |
| 07290114061025 | Standard |
| 17290114061015 | Standard |
| 17290114061008 | Standard |
| 07290114060998 | Standard |
| 07290114060981 | Standard |
| 07290114060974 | Standard |
| 17290014954103 | Sterile Nexframe/Starfix Stainless Steel Guide Tube (cannula) and Stylet |