| Primary Device ID | B0161177000EZ0 |
| NIH Device Record Key | ea5fc04c-b0ea-4e97-a2af-f4ba4fd7b68e |
| Commercial Distribution Discontinuation | 2019-06-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Elekta IMF (Isocentric Mounting Fixture) |
| Version Model Number | 1177000EZ |
| Catalog Number | 1177000EZ |
| Company DUNS | 122240021 |
| Company Name | SUN NUCLEAR CORP. |
| 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 | 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B0161177000EZ0 [Primary] |
| IYE | Accelerator, Linear, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-06-21 |
| Device Publish Date | 2017-01-14 |
| B0161177000EZ0 | Accessory to the 1177 MapCHECK2 . |
| 05060608880638 | Accessory to the 1177 MapCHECK2 . |