| Primary Device ID | 00850376007505 |
| NIH Device Record Key | 29a0694d-648c-43b4-ade9-00da682d3ad4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearPoint Inflexion IMRIS Head Fixation Frame |
| Version Model Number | CP-INHFF-232-01 |
| Catalog Number | CP-INHFF-232-01 |
| 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 | false |
| Lot Batch | true |
| 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 | 00850376007505 [Primary] |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-01 |
| Device Publish Date | 2021-01-22 |
| 08503760070501 | Inflexion Head Fixation Frame fits IMRIS surgical tables |
| 00850376007505 | Inflexion Head Fixation Frame fits IMRIS surgical tables |