| Primary Device ID | 07540180000221 |
| NIH Device Record Key | 0714bf0f-d1f0-4b58-87b9-6a9d622147ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clarity® |
| Version Model Number | 9310-00044 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540180000221 [Primary] |
| KPQ | System, simulation, radiation therapy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-06-30 |
| Device Publish Date | 2020-05-22 |
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| 07340201502273 - Leksell Stereotactic System | 2025-09-25 Post Insulated anterior |
| 07340201503317 - Leksell Stereotactic System | 2025-09-25 Instrument Screwdriver, Double |
| 07340201502440 - Leksell Stereotactic System | 2025-09-25 Ear Plug Holders |
| 07340201502921 - Leksell Stereotactic System | 2025-09-25 Slotted Front Piece |
| 07340201502914 - Leksell Stereotactic System | 2025-09-25 Post Insulated posterior long |
| 07340201502488 - Leksell Stereotactic System | 2025-09-25 Curved Front Piece |