| Primary Device ID | 07340048306584 |
| NIH Device Record Key | 68d31340-85cb-4565-82de-d4e6d0c30038 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leksell Gamma Knife Icon |
| Version Model Number | 1030401 |
| 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 | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07340048306584 [Primary] |
| IWB | System, radiation therapy, radionuclide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 07340048304917 | PATIENT MARKERS (10 PCS) |
| 07340048306584 | QA+ TOOL |
| 07340048306577 | MR HEAD SUPPORT PERFEXION |
| 07340048306560 | MR PHILIPS INTERFACE |
| 07340048305624 | PHANTOM BASE PLATE |
| 07340048305587 | LEKSELL GAMMA KNIFE ICON |
| 07340048304962 | MR HEAD SUPPORT PERFEXION |
| 07340048304955 | MASK ADAPTER ASM |
| 07340048304924 | PATIENT MARKERS (10 PCS) |
| 07340048304634 | LGK MASKS EFFICAST (1 PCS) |
| 07340048304610 | LGK MASK NANOR (1 PCS) |
| 07340048304566 | ICON PATIENT CUSION KLARITY |
| 07340048311779 | LEKSELL VANTAGE ADAPTER LGK |