| Primary Device ID | 00816589021219 |
| NIH Device Record Key | 07b4860c-4271-44b4-b5c7-c0acc85aecdd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fiducial Marker, Sterile |
| Version Model Number | 21251 |
| Company DUNS | 021415875 |
| Company Name | MONTERIS MEDICAL INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816589021219 [Primary] |
| JAC | System, X-Ray, Film Marking, Radiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-17 |
| Device Publish Date | 2025-02-07 |
| 00816589021219 - Fiducial Marker, Sterile | 2025-02-17 |
| 00816589021219 - Fiducial Marker, Sterile | 2025-02-17 |
| 00816589021202 - Mini-Bolt System | 2024-11-20 1.6mm Mini-Bolt Accessory Kit, Refurbished |
| 00816589021226 - Mini-Bolt System | 2024-08-16 Stryker Precision Targeting System - 4.5mm Drill Guide, Packaged |
| 00816589021196 - Mini-Bolt System | 2024-05-28 Mini-Bolt VUE Accessory Kit |
| 00816589021189 - Mini-Bolt System | 2024-03-29 VUE Extractor Tool |
| 00816589021585 - Mini-Bolt System | 2024-01-10 NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe |
| 00816589021158 - Mini-Bolt System | 2023-12-28 1.6mm Mini-Bolt Accessory Kit |
| 00816589021561 - Mini-Bolt System | 2023-12-28 1.6mm Mini-Bolt and Cap, Sterile Packaged |