| Primary Device ID | 05060191071604 |
| NIH Device Record Key | ecef7be4-b353-4db5-a74d-8f30eed17a06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elekta Medical Linear Accelerator |
| Version Model Number | 1555143 |
| 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 | 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 |
| systems.support.na@elekta.com | |
| Phone | +1(855)693-5358 |
| systems.support.na@elekta.com | |
| Phone | +1(855)693-5358 |
| systems.support.na@elekta.com | |
| Phone | +1(855)693-5358 |
| systems.support.na@elekta.com | |
| Phone | +1(855)693-5358 |
| systems.support.na@elekta.com | |
| Phone | +1(855)693-5358 |
| systems.support.na@elekta.com | |
| Phone | +1(855)693-5358 |
| systems.support.na@elekta.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060191071604 [Primary] |
| IYE | Accelerator, linear, medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-09 |
| Device Publish Date | 2021-07-30 |
| 05060191071604 | Elekta Harmony Pro |
| 05060191071581 | Elekta Harmony |
| 05060191071574 | Versa HD™ |
| 05060191071550 | Elekta Synergy® |
| 05060191071543 | Elekta Infinity™ |
| 05060191071529 | Versa HD™ |
| 05060191071512 | Elekta Infinity™ |
| 05060191071505 | Elekta Synergy® |