Array NGS-SFA-01-2
GUDID 00850359007904
SMARTFrame Array Kit, OR-MRI
CLEARPOINT NEURO, INC.
Neurological stereotactic surgery system| Primary Device ID | 00850359007904 |
| NIH Device Record Key | 3784f59e-7fa7-4e13-beca-2914ef0b09d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Array |
| Version Model Number | NGS-SFA-01-2 |
| Catalog Number | NGS-SFA-01-2 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850359007904 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202575
FDA Product Code
| HAW | Neurological Stereotaxic Instrument |
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 | 2021-04-15 |
| Device Publish Date | 2021-04-07 |
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 98824918 not registered Live/Pending |
Giddy Ideas, LLC 2024-10-28 |
 ARRAY 98710446 not registered Live/Pending |
Kohler Co. 2024-08-21 |
 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 |
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