Primary Device ID | 00850359007966 |
NIH Device Record Key | bd7b126f-1173-46c5-b293-ecf314364959 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ClearPoint Maestro |
Version Model Number | CPM-SFW-1 |
Catalog Number | CPM-SFW-1 |
Company DUNS | 959181160 |
Company Name | CLEARPOINT NEURO, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850359007966 [Primary] |
QIH | Automated Radiological Image Processing Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-12 |
Device Publish Date | 2022-10-04 |
00850047354051 - ClearPoint Mobile Equipment Cart | 2024-05-24 ClearPoint Mobile Equipment Cart |
00850047354068 - SMARTFrame Expanded Accessory Kit, 5 Fr | 2024-05-24 SMARTFrame Expanded Accessory Kit, 5 Fr |
00850047354075 - SMARTFrame Expanded Accessory Kit, 7 Fr | 2024-05-24 SMARTFrame Expanded Accessory Kit, 7 Fr |
00850376007925 - Bone Anchor | 2024-05-24 Bone Anchor |
00850047354006 - SmartFrame OR | 2024-03-19 SmartFrame OR Drill Guide, 5.4mm |
00850047354013 - SmartFrame OR | 2024-03-19 SmartFrame OR Skull Mount Base |
00850047354020 - SmartFrame OR | 2024-03-19 SmartFrame OR Scalp Mount Base |
00850047354037 - SmartFrame OR | 2024-03-19 SmartFrame OR Depth Setter Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLEARPOINT MAESTRO 90533465 not registered Live/Pending |
CLEARPOINT NEURO, INC. 2021-02-18 |