| Primary Device ID | 00884838059238 |
| NIH Device Record Key | 45d2880e-a061-4f88-892b-d871645ef68a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MR-CT Roadmap |
| Version Model Number | MR-CT Roadmap R1 |
| Catalog Number | 001004 |
| Company DUNS | 413819707 |
| Company Name | Philips Medical Systems Nederland B.V. |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838059238 [Primary] |
| OWB | Interventional Fluoroscopic X-Ray System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 8 |
| Public Version Date | 2019-12-02 |
| Device Publish Date | 2016-09-24 |
| 00884838127609 - DUNLEE SENTINELLE | 2025-01-20 ADD-ON ACCESSORIES BREAST SEN MR SET contains - 2 Fiducial Marker Grid Block Assembly and 1 BREAST GRID (USER STERILIZED) |
| 00884838119277 - Philips Sentinelle | 2024-12-25 dS 1.5T Interface Box |
| 00884838119284 - Philips Sentinelle | 2024-12-25 dS 3.0T Interface Box |
| 00884838119291 - Philips Sentinelle | 2024-12-25 dS 1.5T 8CH Medial |
| 00884838119307 - Philips Sentinelle | 2024-12-25 dS 3.0T 8CH Medial |
| 00884838119314 - Philips Sentinelle | 2024-12-25 dS 1.5T 4CH Lateral Left |
| 00884838119321 - Philips Sentinelle | 2024-12-25 dS 3.0T 4CH Lateral Left |
| 00884838119338 - Philips Sentinelle | 2024-12-25 dS 1.5T 4CH Lateral Right |