| Primary Device ID | 07340201501382 |
| NIH Device Record Key | fc47f24a-e895-41f1-a05d-1ef33405fae5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leksell Vantage Stereotactic System |
| Version Model Number | 1040014 |
| Catalog Number | 1040014 |
| Company DUNS | 353272181 |
| Company Name | Elekta Solutions AB |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07340201501382 [Direct Marking] |
| GS1 | 07340201501399 [Primary] |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-26 |
| Device Publish Date | 2024-06-18 |
| 07340201502198 | Leksell Vantage™ Head Frame |
| 07340201501825 | Leksell Vantage™ Head Frame |
| 07340201501764 | LEKSELL VANTAGE FRAME HOLDER |
| 07340201501832 | MRI FIDUCIAL BOX |
| 07340201501535 | Leksell Vantage™ Arc Tray |
| 07340201501382 | LEKSELL VANTAGE CT FIDUCIAL BOX |
| 07340048306065 | FirmFix™ Ruler |
| 07340201501757 | LEKSELL VANTAGE CT INTERFACE |
| 07340201501719 | Vantage™ Frame Holder extension |
| 07340201501658 | VANTAGE STARBURST 3/8 |
| 07340201501634 | VANTAGE RADIOLUCENT STARBURST 1/2" |
| 07340201501276 | FirmFix™ 2 |
| 07340201501252 | FirmFix™ 1 |
| 07340201501313 | FirmFix™ 4 |
| 07340201501290 | FirmFix™ 3 |
| 07340201501337 | FirmFix™ 5 |
| 07340201501887 | LEKSELL VANTAGE ARC SYSTEM |
| 07340201501511 | LEKSELL VANTAGE ARC SYSTEM |
| 07340201502129 | LEKSELL VANTAGE CARRIER |
| 07340201501504 | Leksell Vantage™ Support Arc |
| 07340201501528 | Leksell Vantage Key |
| 07340201501924 | GUIDE SLIDE |
| 07340201501917 | STOP SLIDE |
| 07340201501894 | SUPPORT ARC COMPLETE |
| 07340201501962 | ARC Y SCALE LEFT |
| 07340201501955 | ARC Y SCALE RIGHT |
| 07340201501948 | ARC SLIDE RIGHT |
| 07340201501931 | ARC SLIDE LEFT |
| 07340201501870 | ARC SUPPORT RIGHT |
| 07340201501863 | ARC SUPPORT LEFT |
| 07340201502242 | CT TABLE FIXATION TOSHIBA |
| 07340201502235 | CT TABLE FIXATION GE |
| 07340201502228 | CT TABLE FIXATION PHILIPS |
| 07340201502211 | CT table Fixation Siemens |
| 07340201502204 | CT TABLE FIXATION UNIVERSAL |
| 07340201501498 | Leksell Vantage Head Frame Positioning Band |
| 07340201501351 | LEKSELL VANTAGE CROSS-HAIRS |
| 07340201501610 | MRI COIL ADAPTER UNIVERSAL |
| 07340201501597 | MRI COIL ADAPTER LARGE |
| 07340201501573 | MRI COIL ADAPTER LOWER STOP |
| 07340201501559 | MRI COIL ADAPTER UPPER STOP |