EnVisio ENVISIO-SYS
GUDID 00851674008034
EnVisio Navigation System: contains EnVisio Navigation Patient Pad and EnVisio Navigation System Heads Up Display
ELUCENT MEDICAL, INC.
Imaging lesion localization marker, implantable| Primary Device ID | 00851674008034 |
| NIH Device Record Key | 0ec4e1ae-9744-44f2-9714-93ba8d47d400 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EnVisio |
| Version Model Number | ENVISIO-SYS |
| Catalog Number | ENVISIO-SYS |
| Company DUNS | 079322481 |
| Company Name | ELUCENT MEDICAL, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851674008034 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183400
FDA Product Code
| NEU | Marker, Radiographic, Implantable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2019-04-15 |
On-Brand Devices [EnVisio]
| 00851674008065 | EnVisio Navigation System Heads Up Display |
| 00851674008058 | Envisio Navigation Patient Pad |
| 00851674008041 | Envisio Navigator and Calibration Disk |
| 00851674008034 | EnVisio Navigation System: contains EnVisio Navigation Patient Pad and EnVisio Navigation System |
| 00851674008225 | EnVisio Navigation System Heads Up Display |
| 00851674008072 | Screenless version of the Envisio Navigator and Calibration Disk |
| 10085167400822 | EnVisio Navigation System Heads Up Display Version 2 |
| 00851674008348 | Screenless version of the Envisio Navigator and SmartCal Calibration Disk |
| 00851674008232 | Envisio Navigation Patient Pad - RF Sponge Detection Compatible |
Trademark Results [EnVisio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENVISIO 98774175 not registered Live/Pending |
Elucent Medical, Inc. 2024-09-27 |
 ENVISIO 87410808 not registered Live/Pending |
Elucent Medical, Inc. 2017-04-13 |
 ENVISIO 79372229 not registered Live/Pending |
Lightcast Discovery Ltd 2022-12-09 |
 ENVISIO 78426101 3159992 Dead/Cancelled |
Eastman Chemical Company 2004-05-27 |
 ENVISIO 77594119 3920252 Dead/Cancelled |
Cadwell Industries, Inc. 2008-10-16 |
 ENVISIO 76149980 not registered Dead/Abandoned |
Class One Orthodontics, Inc. 2000-10-19 |
 ENVISIO 75443160 not registered Dead/Abandoned |
MasterCard International Incorporated 1998-03-02 |
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