| Primary Device ID | 00850359007744 |
| NIH Device Record Key | e50c1a1d-2c81-4d91-bf01-7857de15f7b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearPoint Array |
| Version Model Number | CPA-SFW-11-1 |
| 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 | 00850359007744 [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 |
| 00850359007744 | ClearPoint Lite Software |
| 00850376007659 | ClearPoint Array Software Version 1.1 |
| 00850376007895 | ClearPoint Array v1.2.x Neuro Workstation |
| 00850376007871 | ClearPoint Array Software Version 1.2 |