| Primary Device ID | 00850359007935 |
| NIH Device Record Key | 32397f13-fc42-4187-8a60-21ce33514eaf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartFrame Array Thumbwheel Extension |
| Version Model Number | NGS-SFA-TE-01 |
| 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 | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850359007935 [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 | 2021-04-15 |
| Device Publish Date | 2021-04-07 |
| 00850047354006 - SmartFrame OR | 2024-03-19 SmartFrame OR Drill Guide, 5.4mm |
| 00850047354013 - SmartFrame OR | 2024-03-19 SmartFrame OR Skull Mount Base |
| 00850047354020 - SmartFrame OR | 2024-03-19 SmartFrame OR Scalp Mount Base |
| 00850047354037 - SmartFrame OR | 2024-03-19 SmartFrame OR Depth Setter Kit |
| 00850047354044 - SmartFrame OR | 2024-03-19 SmartFrame OR Bone Screw Fiducial Kit |
| 00850376007932 - SmartFrame OR | 2024-03-19 SmartFrame OR Kit |
| 00850376007949 - SmartFrame OR | 2024-03-19 SmartFrame OR ClearPointer Kit - StealthStation |
| 00850376007956 - SmartFrame OR | 2024-03-19 SmartFrame OR Drill Guide Kit, 3.4 & 4.5mm |