ClearPoint Maestro CPM-SFW-1
GUDID 00850359007966
ClearPoint Maestro Brain Model Software Version 1.0
CLEARPOINT NEURO, INC.
Image segmentation application software| Primary Device ID | 00850359007966 |
| NIH Device Record Key | bd7b126f-1173-46c5-b293-ecf314364959 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearPoint Maestro |
| Version Model Number | CPM-SFW-1 |
| Catalog Number | CPM-SFW-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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850359007966 [Primary] |
FDA Product Code
| QIH | Automated Radiological Image Processing Software |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-12 |
| Device Publish Date | 2022-10-04 |
Devices Manufactured by CLEARPOINT NEURO, INC.
| 00850047354082 - ClearPoint | 2025-05-29 Depth Stops (6pk) |
| 00850047354099 - ClearPoint | 2025-02-13 ClearPoint - Software Version 3.0 |
| 00850047354136 - ClearPoint | 2025-02-13 ClearPoint Neuro Workstation - Win 11 |
| 00850047354105 - SmartFlow | 2024-12-03 SmartFlow Neuro Cannula, 16 ga, .008" ID x 4 ft x 18mm tip |
| 00850047354112 - SmartFlow | 2024-12-03 SmartFlow Neuro Cannula, 16 ga, .008" ID x 10 ft x 18mm tip |
| 00850047354051 - ClearPoint Mobile Equipment Cart | 2024-05-24 ClearPoint Mobile Equipment Cart |
| 00850047354068 - SMARTFrame Expanded Accessory Kit, 5 Fr | 2024-05-24 SMARTFrame Expanded Accessory Kit, 5 Fr |
| 00850047354075 - SMARTFrame Expanded Accessory Kit, 7 Fr | 2024-05-24 SMARTFrame Expanded Accessory Kit, 7 Fr |
Trademark Results [ClearPoint Maestro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARPOINT MAESTRO 90533465 not registered Live/Pending |
CLEARPOINT NEURO, INC. 2021-02-18 |
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