| Primary Device ID | 00817421022852 |
| NIH Device Record Key | 360e0913-c28c-4575-a0fa-034ce794dace |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-Guide FastMap |
| Version Model Number | P011942 |
| Company DUNS | 026096247 |
| Company Name | XNAV TECHNOLOGIES LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 00817421022852 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-02 |
| Device Publish Date | 2024-06-24 |
| 00817421022791 - X-Guide | 2024-10-16 EDX-S Tracker Arm, Vertical, Center |
| 00817421022784 - X-Guide | 2024-09-16 X-Guide 3.5.2 Linux Software |
| 00817421022814 - X-Guide | 2024-09-16 X-Guide 3.5.4 Linux Software |
| 00817421022821 - X-Guide | 2024-09-16 X-Guide 3.5.8 Linux Software |
| 00817421022838 - X-Guide | 2024-07-02 X-Guide 3.6.0 Linux Software |
| 00817421022852 - X-Guide FastMap | 2024-07-02FastMap Navigated Photogrammetry Software |
| 00817421022852 - X-Guide FastMap | 2024-07-02 FastMap Navigated Photogrammetry Software |
| 00817421022623 - X-Guide | 2024-03-25 EDX-S Tracker Arm, Horizontal, Left |
| 00817421022630 - X-Guide | 2024-03-25 EDX-S Tracker Arm, Vertical, Right |