| Primary Device ID | 00850359007843 |
| NIH Device Record Key | 8802a283-0e81-4bfd-b432-9d56099720fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartFrame XG-7 Fr |
| Version Model Number | NGS-SF-02-11-7 |
| Catalog Number | NGS-SF-02-11-7 |
| Company DUNS | 959181160 |
| Company Name | CLEARPOINT NEURO, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00850359007843 [Primary] |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-01 |
| Device Publish Date | 2021-01-22 |
| 08503590070849 | MRI Guided trajectory frame that is compatible with devices with ~ 7 Fr OD |
| 00850359007843 | MRI Guided trajectory frame that is compatible with devices with ~ 7 Fr OD |