EnVisio ENVISIO-HUD2
GUDID 00851674008225
EnVisio Navigation System Heads Up Display
ELUCENT MEDICAL, INC.
Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable| Primary Device ID | 00851674008225 |
| NIH Device Record Key | 11f766aa-58e2-4954-8739-45b4d0a7a4d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EnVisio |
| Version Model Number | ENVISIO-HUD2 |
| Catalog Number | ENVISIO-HUD2 |
| 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 | 00851674008225 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-17 |
| Device Publish Date | 2020-08-07 |
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 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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