| Primary Device ID | 07340048311793 |
| NIH Device Record Key | ace932fc-fb13-4aed-bfd5-2140c85f82d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leksell Stereotactic System Neurosurgical Instruments |
| Version Model Number | 1075647 |
| Company DUNS | 507772663 |
| Company Name | Elekta Instrument 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 | 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 |
| 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 | 07340048311793 [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 | 2021-06-08 |
| Device Publish Date | 2021-05-31 |
| 07340048311892 - Leksell Vantage Stereotactic System | 2022-11-14 ARC CARRIER |
| 07340048311793 - Leksell Stereotactic System Neurosurgical Instruments | 2021-06-08INSERTION RULER |
| 07340048311793 - Leksell Stereotactic System Neurosurgical Instruments | 2021-06-08 INSERTION RULER |
| 07340048312011 - Leksell Vantage Stereotactic System | 2021-04-07 MRI COIL ADAPTER UNIVERSAL |
| 07340048311700 - Leksell Gamma Knife Perfexion/Icon | 2021-04-05 FILM HOLDER VANTAGE LGK |
| 07340048311731 - Leksell Gamma Knife Perfexion/Icon | 2021-04-05 Dosimetry Phantom Vantage Base |
| 07340048311755 - Leksell Gamma Knife Perfexion/Icon | 2021-04-05 QA TOOL VANTAGE LGK |
| 07340048311762 - Leksell Gamma Knife Perfexion/Icon | 2021-04-05 Dosimetry Phantom Vantage LGK |
| 07340048311779 - Leksell Gamma Knife Icon | 2021-04-05 LEKSELL VANTAGE ADAPTER LGK |