| Primary Device ID | BN981BN001021 |
| NIH Device Record Key | f63b1587-1e2a-4246-9b7f-25b5e9c70b9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bolt Navigation |
| Version Model Number | BN001-02 |
| Catalog Number | BN001-02 |
| Company DUNS | 075673122 |
| Company Name | Circinus Medical Technology LLC |
| 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 |
| Phone | 8666823422 |
| info@boltnav.com | |
| Phone | 8666823422 |
| info@boltnav.com | |
| Phone | 8666823422 |
| info@boltnav.com | |
| Phone | 8666823422 |
| info@boltnav.com | |
| Phone | 8666823422 |
| info@boltnav.com | |
| Phone | 8666823422 |
| info@boltnav.com | |
| Phone | 8666823422 |
| info@boltnav.com | |
| Phone | 8666823422 |
| info@boltnav.com | |
| Phone | 8666823422 |
| info@boltnav.com | |
| Phone | 8666823422 |
| info@boltnav.com | |
| Phone | 8666823422 |
| info@boltnav.com | |
| Phone | 8666823422 |
| info@boltnav.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | BN981BN001021 [Primary] |
| OWB | Interventional Fluoroscopic X-Ray System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-25 |
| Device Publish Date | 2024-11-15 |
| B981BN00201101 | Bolt Navigation Sterile Case used with the Bolt Navigation System |
| B981BN0010101 | Bolt Navigation Unit |
| BN981BN002023 | Bolt Navigation Case |
| BN981BN001021 | Bolt Navigation Unit, Gen 2.0 |