| Primary Device ID | 00850359007911 |
| NIH Device Record Key | eb47a19c-b05b-4244-9980-1b80343309c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearPoint Array Workstation |
| Version Model Number | CPA-WK-01 |
| Company DUNS | 959181160 |
| Company Name | CLEARPOINT NEURO, 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 | false |
| Serial Number | true |
| 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 | 00850359007911 [Primary] |
| HAW | Neurological Stereotaxic Instrument |
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-15 |
| Device Publish Date | 2021-04-07 |
| 00850047354099 - ClearPoint | 2025-02-13 ClearPoint - Software Version 3.0 |
| 00850047354136 - ClearPoint | 2025-02-13 ClearPoint Neuro Workstation - Win 11 |
| 00850047354105 - SmartFlow | 2024-12-03 SmartFlow Neuro Cannula, 16 ga, .008" ID x 4 ft x 18mm tip |
| 00850047354112 - SmartFlow | 2024-12-03 SmartFlow Neuro Cannula, 16 ga, .008" ID x 10 ft x 18mm tip |
| 00850047354051 - ClearPoint Mobile Equipment Cart | 2024-05-24 ClearPoint Mobile Equipment Cart |
| 00850047354068 - SMARTFrame Expanded Accessory Kit, 5 Fr | 2024-05-24 SMARTFrame Expanded Accessory Kit, 5 Fr |
| 00850047354075 - SMARTFrame Expanded Accessory Kit, 7 Fr | 2024-05-24 SMARTFrame Expanded Accessory Kit, 7 Fr |
| 00850376007925 - Bone Anchor | 2024-05-24 Bone Anchor |