SMARTFrame Array NGS-SFA-DG-03
GUDID 00850376007710
SmartFrame® Array Offset & Center Guides, 5.4mm
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| Primary Device ID | 00850376007710 |
| NIH Device Record Key | ad76ff5c-a151-4df9-b4d8-3fb8ba8bca66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMARTFrame Array |
| Version Model Number | NGS-SFA-DG-03 |
| Catalog Number | NGS-SFA-DG-03 |
| Company DUNS | 959181160 |
| Company Name | CLEARPOINT NEURO, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | 00850376007710 [Primary] |
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 | 2022-04-22 |
| Device Publish Date | 2022-04-14 |
On-Brand Devices [SMARTFrame Array]
| 00850359007928 | Guide tube kit for SmartFrame Array-Contains guide tubes and device locks |
| 00850376007598 | Array Kit with navigation frame, used mainly for burr hole procedures |
| 00850376007710 | SmartFrame® Array Offset & Center Guides, 5.4mm |
Trademark Results [SMARTFrame Array]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTFRAME ARRAY 88921112 not registered Live/Pending |
ClearPoint Neuro, Inc. 2020-05-18 |
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