OptiVu™ Mixed Reality OVMR-SW-2-0005
GUDID 00887868554483
Orthosoft Inc
Radiology DICOM image processing application software| Primary Device ID | 00887868554483 |
| NIH Device Record Key | c9610501-07a2-401a-bb2b-a7015fb40a23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiVu™ Mixed Reality |
| Version Model Number | OVMR-SW-2-0005 |
| Catalog Number | OVMR-SW-2-0005 |
| Company DUNS | 205670032 |
| Company Name | Orthosoft 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868554483 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220733
FDA Product Code
| LLZ | System, image processing, radiological |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
[00887868554483]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-10 |
| Device Publish Date | 2023-03-31 |
On-Brand Devices [OptiVu™ Mixed Reality]
| 00887868554490 | OVMR-SW-2-0006 |
| 00887868554483 | OVMR-SW-2-0005 |
| 00887868579226 | OVMR-SW-2-0202 |
| 00887868579219 | OVMR-SW-2-0201 |
Trademark Results [OptiVu]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTIVU 90524364 not registered Live/Pending |
Flynn Canada Ltd. 2021-02-11 |
 OPTIVU 90519938 not registered Live/Pending |
Zimmer US, Inc. 2021-02-09 |
 OPTIVU 85904879 not registered Dead/Abandoned |
OPTIMAL FUSION, INC. 2013-04-15 |
 OPTIVU 75651771 not registered Dead/Abandoned |
Optimize, Inc. 1999-03-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.