| Primary Device ID | 00850359007881 |
| NIH Device Record Key | 7b669827-e045-4360-bf59-41f3b45b45cb |
| Commercial Distribution Discontinuation | 2035-04-30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartFrame XG TwistPoint Kit w/TE-5 Fr |
| Version Model Number | CP-NGS-11-TP45-XG-5 |
| Catalog Number | CP-NGS-11-TP45-XG-5 |
| 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 | false |
| 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 | 00850359007881 [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 |
| 08503590070887 | A procedure kit that packages several individually boxed and packaged ClearPoint kits together. |
| 00850359007881 | A procedure kit that packages several individually boxed and packaged ClearPoint kits together. |