omniTRAX™ Active Patient Tracker Starter Kit 5670091
GUDID 00841436110952
Non-sterile markers (5) for use with MR and US enviroments, reusable non-sterile general purpose electromagnetic sensor for use with 3D Guidance driveBAY™, drive BAY 2, trakstar™ or trakSTAR 2 trackers
CIVCO MEDICAL INSTRUMENTS CO., INC.
Electromagnetic device tracking system fiducial marker| Primary Device ID | 00841436110952 |
| NIH Device Record Key | 799ac35a-35a9-4e4f-9c9a-2b536576d7be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | omniTRAX™ Active Patient Tracker Starter Kit |
| Version Model Number | 5670091 |
| Catalog Number | 5670091 |
| Company DUNS | 134614411 |
| Company Name | CIVCO MEDICAL INSTRUMENTS CO., 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com |
Device Dimensions
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
| Width | 7 Inch |
| Length | 1.95 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436110952 [Primary] |
| GS1 | 20841436118174 [Direct Marking] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143396
FDA Product Code
| LNH | System, nuclear magnetic resonance imaging |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-22 |
On-Brand Devices [omniTRAX™ Active Patient Tracker Starter Kit]
| 00841436111768 | Non-sterile markers (5) for use with MR and US enviroments, reusable non-sterile general purpose |
| 00841436110952 | Non-sterile markers (5) for use with MR and US enviroments, reusable non-sterile general purpose |
Trademark Results [omniTRAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNITRAX 85102121 4030847 Dead/Cancelled |
University of Washington 2010-08-06 |
 OMNITRAX 79170519 not registered Live/Pending |
Omniroll AG 2015-05-12 |
 OMNITRAX 78611180 3837987 Live/Registered |
SENSTAR CORPORATION 2005-04-18 |
 OMNITRAX 78440673 3081731 Live/Registered |
OT INTELLECTUAL PROPERTY, LLC 2004-06-24 |
 OMNITRAX 77355005 3533420 Live/Registered |
OmniTRAX, Inc. 2007-12-18 |
 OMNITRAX 74365941 1909465 Live/Registered |
Omnitrax, Inc. 1993-03-05 |
 OMNITRAX 74365928 1918987 Dead/Cancelled |
Omnitrax, Inc. 1993-03-05 |
 OMNITRAX 74365265 not registered Dead/Abandoned |
Omnitrax, Inc. 1993-03-05 |
 OMNITRAX 73642529 1681795 Dead/Cancelled |
PICCIANO, LOUIS 1987-02-02 |
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