| Primary Device ID | 07340048305112 |
| NIH Device Record Key | f0fa6d25-a402-4a0f-942b-2bbf3d783671 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leksell Gamma Knife Perfexion/Icon |
| Version Model Number | 1002637 |
| Company DUNS | 507772663 |
| Company Name | Elekta Instrument AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07340048305112 [Primary] |
| HAW | Neurological stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07340048305112]
Moist Heat or Steam Sterilization
[07340048305112]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-19 |
| Device Publish Date | 2020-10-09 |
| 07340048309516 | FRAME FIXATION ADAPTER |
| 07340048307963 | FRAME FIXATION ADAPTER |
| 07340048306591 | CC EXCHANGE TOOL |
| 07340048306553 | CLEARENCE CHECK TOOL |
| 07340048306546 | QA FILM HOLDER |
| 07340048306522 | FRAME CAP |
| 07340048306454 | DOSIMETRY PHANTOM |
| 07340048306188 | RADIATION PHANTOM WITH CASSETTES |
| 07340048305617 | PHANTOM ADAPTER COMPLETE |
| 07340048306447 | LEKSELL GAMMA KNIFE DOSIMETRY PHANTOM |
| 07340048305112 | POST INSULATED LONG POSTERIOR |
| 07340048311762 | Dosimetry Phantom Vantage LGK |
| 07340048311755 | QA TOOL VANTAGE LGK |
| 07340048311731 | Dosimetry Phantom Vantage Base |
| 07340048311700 | FILM HOLDER VANTAGE LGK |