ClearPoint Maestro CPM-SFW-1
GUDID 00850359007966
ClearPoint Maestro Brain Model Software Version 1.0
CLEARPOINT NEURO, INC.
Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software 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.
| 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 |
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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