| Primary Device ID | 00863593000204 |
| NIH Device Record Key | 3194bd8e-af20-4414-8ff2-5d9f40a72aed |
| Commercial Distribution Discontinuation | 2016-06-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Sirius MRI Marker |
| Version Model Number | C-01-99-0014 |
| Catalog Number | F-01-01-0001 |
| Company DUNS | 003065466 |
| Company Name | C4 IMAGING, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 713-280-1843 |
| abright@c4imaging.com |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00863593000204 [Primary] |
| KXK | Source, Brachytherapy, Radionuclide |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00863593000204]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-02-19 |
| 00863593000211 | The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction wit |
| 00863593000204 | The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction wit |