SmartFrame OR NGS-SFOR-CP-01
GUDID 00850376007949
SmartFrame OR ClearPointer Kit - StealthStation
Clearpoint Neuro, Inc.
Neurological stereotactic surgery system| Primary Device ID | 00850376007949 |
| NIH Device Record Key | 1073176c-a7dc-4be9-8837-f09bf06be1a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartFrame OR |
| Version Model Number | NGS-SFOR-CP-01 |
| Catalog Number | NGS-SFOR-CP-01 |
| Company DUNS | 119078557 |
| Company Name | Clearpoint Neuro, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com | |
| Phone | 949-900-6833 |
| quality@clearpointneuro.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850376007949 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233155
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 | 2024-03-19 |
| Device Publish Date | 2024-03-11 |
On-Brand Devices [SmartFrame OR]
| 00850376007956 | SmartFrame OR Drill Guide Kit, 3.4 & 4.5mm |
| 00850376007949 | SmartFrame OR ClearPointer Kit - StealthStation |
| 00850376007932 | SmartFrame OR Kit |
| 00850047354044 | SmartFrame OR Bone Screw Fiducial Kit |
| 00850047354037 | SmartFrame OR Depth Setter Kit |
| 00850047354020 | SmartFrame OR Scalp Mount Base |
| 00850047354013 | SmartFrame OR Skull Mount Base |
| 00850047354006 | SmartFrame OR Drill Guide, 5.4mm |
Trademark Results [SmartFrame OR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTFRAME OR 98404698 not registered Live/Pending |
CLEARPOINT NEURO, INC. 2024-02-14 |
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