ARVIS ®
GUDID 00850012315650
Registration Stylus
Insight Medical Systems, Inc.
Surgical optical-tracking spatial marker, reusable| Primary Device ID | 00850012315650 |
| NIH Device Record Key | 6b301c33-50c7-4e32-b9fd-68bdb28166d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARVIS ® |
| Version Model Number | 18600 |
| Company DUNS | 080536842 |
| Company Name | Insight Medical Systems, 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 | 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850012315650 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203115
FDA Product Code
| OLO | Orthopedic Stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
[00850012315650]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-06 |
| Device Publish Date | 2023-09-28 |
On-Brand Devices [ARVIS ®]
| 00850012315384 | Femoral Slot Adapter, Parallel |
| 00850012315377 | Charger, 25W USB-C, USA |
| 00850012315360 | Landmark Punch |
| 00850012315353 | Adapter, DJO Impactor |
| 00850012315346 | Femoral Reference Mount, Right |
| 00850012315339 | Femoral Reference Mount, Left |
| 00850012315322 | Distal Guide Tracker |
| 00850012315315 | ARVIS Hip and Knee Instrument Set, Packaged |
| 00850012315308 | ARVIS Surgical Navigation System |
| 00850012315292 | ARVIS Charger Cord, USA |
| 00850012315285 | ARVIS Charger Power Supply |
| 00850012315278 | ARVIS Battery Charger |
| 00850012315261 | ARVIS Battery |
| 00850012315254 | ARVIS Computer Module |
| 00850012315247 | ARVIS Eyepiece Cable |
| 00850012315230 | ARVIS Belt Pack |
| 00850012315223 | ARVIS Eyepiece |
| 00850012315216 | Femoral Reference Mount |
| 00850012315209 | Tracker C |
| 00850012315193 | Tracker A |
| 00850012315186 | Distal Guide |
| 00850012315179 | Adjustable Cutting Block |
| 00850012315162 | Tibial Reference Mount, Right |
| 00850012315155 | Tibial Reference Mount, Left |
| 00850012315148 | Tibial Slot Adapter |
| 00850012315131 | Femoral Slot Adapter |
| 00850012315124 | 2.5mm Ball Driver |
| 00850012315117 | 3.5mm Hex Driver |
| 00850012315100 | Tracker B |
| 00850012315094 | Impactor V-Block Assembly |
| 00850012315087 | Tracker D |
| 00850012315070 | Reference Tracker 1 |
| 00850012315063 | Reference Mount |
| 00850012315056 | Registration Stylus |
| 00850012315049 | Pin Caddy Lid |
| 00850012315032 | Pin Caddy |
| 00850012315025 | ARVIS Hip and Knee Instrument Set |
| 00850012315018 | Instrument Tray Lid |
| 00850012315001 | Instrument Tray Base |
| 00850012315551 | Pin Caddy Lid |
| 00850012315544 | Pin Caddy |
| 00850012315537 | ARVIS Hip and Knee Instrument Set |
| 00850012315520 | Instrument Tray Base |
| 00850012315513 | Registration Stylus |
| 00850012315506 | Tracker A |
| 00850012315490 | Impactor Adapter, DJO |
| 00850012315483 | Tibial Reference Mount, Right |
| 00850012315476 | Tibial Reference Mount, Left |
| 00850012315469 | Adjustable Distal Guide |
| 00850012315452 | Femoral Cutting Block |
Trademark Results [ARVIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARVIS 97496584 not registered Live/Pending |
Insight Medical Systems, Inc. 2022-07-11 |
 ARVIS 90010908 not registered Live/Pending |
Avadh Kalpeshbhai Daxini 2020-06-19 |
 ARVIS 87784344 not registered Live/Pending |
Insight Medical Systems, Inc. 2018-02-05 |
 ARVIS 79054266 not registered Dead/Abandoned |
AREA S.r.l. 2008-04-15 |
 ARVIS 78870393 3778155 Dead/Cancelled |
Special Electronics & Designs, Inc. 2006-04-26 |
 ARVIS 74002374 1692475 Dead/Cancelled |
CONCEPT VISION SYSTEMS, INC. 1989-11-16 |
 ARVIS 73600460 1420711 Dead/Cancelled |
ATLANTIC RICHFIELD COMPANY 1986-05-23 |
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