| Primary Device ID | 00863593000273 |
| NIH Device Record Key | 090abe6e-11c2-43fa-bec5-9359489f6b10 |
| Commercial Distribution Discontinuation | 2022-04-27 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Nova 10 Fiducial Marker |
| Version Model Number | F-01-03-0115 |
| Company DUNS | 003065466 |
| Company Name | C4 IMAGING, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00863593000273 [Primary] |
| NEU | Marker, Radiographic, Implantable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-03 |
| Device Publish Date | 2022-04-25 |
| 00863593000273 - Nova 10 Fiducial Marker | 2022-05-03 |
| 00863593000273 - Nova 10 Fiducial Marker | 2022-05-03 |
| 00863593000242 - Nova 5 | 2021-09-13 The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobal |
| 00863593000259 - Nova 5 | 2021-09-13 The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobal |
| 00863593000235 - HDR MRI Lumen Marker | 2018-07-12 The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline |
| 00863593000204 - Sirius MRI Marker | 2018-07-06 The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sle |
| 00863593000211 - Sirius MRI Marker | 2018-07-06 The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sle |
| 00863593000228 - Sirius MRI Marker NS | 2018-07-06 The SIRIUS MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier |