Array CP-NGS-SFA-MRBH
GUDID 00850376007628
SMARTFrame Array MR Burr Hole Procedure Kit
CLEARPOINT NEURO, INC.
Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system| Primary Device ID | 00850376007628 |
| NIH Device Record Key | 4bbe4b28-eb3d-4798-b099-52746b4c6db5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Array |
| Version Model Number | CP-NGS-SFA-MRBH |
| Catalog Number | CP-NGS-SFA-MRBH |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00850376007628 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202575
FDA Product Code
| HAW | Neurological Stereotaxic Instrument |
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-22 |
| Device Publish Date | 2021-07-14 |
On-Brand Devices [Array]
| 00850376007611 | SMARTFrame Array OR-MR Procedure Kit |
| 00850359007904 | SMARTFrame Array Kit, OR-MRI |
| 00850376007635 | SMARTFrame Array MR Drilling Procedure Kit |
| 00850376007628 | SMARTFrame Array MR Burr Hole Procedure Kit |
| 00850376007604 | SMARTFrame Array Kit, MR Drilling |
Trademark Results [Array]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARRAY 98314174 not registered Live/Pending |
Resolute Business Ventures, LLC 2023-12-14 |
 ARRAY 98282434 not registered Live/Pending |
Solais Lighting, LLC 2023-11-22 |
 ARRAY 98038103 not registered Live/Pending |
Edel Golf, LLC 2023-06-12 |
 ARRAY 98033977 not registered Live/Pending |
Omni-Invictus, LLC 2023-06-08 |
 ARRAY 97848539 not registered Live/Pending |
MOUNTAIN OF ENTERTAINMENT THEATER LLC 2023-03-21 |
 ARRAY 97663386 not registered Live/Pending |
Fellowes, Inc. 2022-11-04 |
 ARRAY 97625008 not registered Live/Pending |
Ascot Underwriting Limited 2022-10-09 |
 ARRAY 97507471 not registered Live/Pending |
ACP of Delaware, Inc. 2022-07-18 |
 ARRAY 97421591 not registered Live/Pending |
AppLovin Corporation 2022-05-20 |
 ARRAY 97321206 not registered Live/Pending |
Access79, Inc. 2022-03-20 |
 ARRAY 90882980 not registered Live/Pending |
AAFFRM, LLC 2021-08-14 |
 ARRAY 90858951 not registered Live/Pending |
Array Networks, Inc. 2021-07-30 |
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