SmartFrame Array NGS-SFA-02-2
GUDID 00850376007598
Array Kit with navigation frame, used mainly for burr hole procedures
CLEARPOINT NEURO, INC.
Neurological stereotactic surgery system| Primary Device ID | 00850376007598 |
| NIH Device Record Key | 5d3f5e10-175b-40fb-aeb5-768174e4fa11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartFrame Array |
| Version Model Number | NGS-SFA-02-2 |
| Catalog Number | NGS-SFA-02-2 |
| 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 | 00850376007598 [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 [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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