| Primary Device ID | 07340201501511 |
| NIH Device Record Key | 0da897b3-6434-489f-9b62-8d62b14df824 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leksell Vantage Stereotactic System |
| Version Model Number | 1040048 |
| Company DUNS | 353272181 |
| Company Name | Elekta Solutions AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07340201501511 [Primary] |
| HAW | Neurological stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
[07340201501511]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-09-09 |
| Device Publish Date | 2024-08-14 |
| 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 |