| Primary Device ID | 10628341930304 |
| NIH Device Record Key | 55125cb6-ec26-4e19-9ecb-b08cb55025cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Koilia Mikros |
| Version Model Number | 1 |
| Catalog Number | BB09-D |
| Company DUNS | 206950904 |
| Company Name | CDR Systems Inc |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 403-850-7035 |
| info@cdrsys.ca |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628341930307 [Primary] |
| GS1 | 10628341930304 [Package] Contains: 00628341930307 Package: [1 Units] In Commercial Distribution |
| 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 | 2020-01-08 |
| Device Publish Date | 2019-12-31 |
| 10628341930502 - EQUILIBRIUM | 2024-02-02 EQUILIBRIUM Rotating Overlay System |
| 10628341930373 - Thermoplastic | 2024-01-08 Thermoplastic Immobilization Materials |
| 10628341930380 - Thermoplastic | 2024-01-08 Thermoplastic Immobilization Mask |
| 10628341930465 - TBI | 2023-03-16 TBI Positioning System With Spoiler |
| 10628341930441 - Freedom | 2023-03-03 Freedom S-Type Overlay |
| 10628341930458 - Freedom | 2023-03-03 Freedom S-Type Overlay (MR Safe) |
| 00628341930406 - Solid Bolus | 2020-05-25 Solid Bolus |
| 10628341930427 - Freedom | 2020-05-25 Freedom Prone Head & Neck Immobilization (MR Conditional) |