| Primary Device ID | 00841436102278 |
| NIH Device Record Key | bbc38f96-c7f9-49ca-9566-cb4d263412c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VirtuTRAX Instrument Navigator |
| Version Model Number | 610-1152 |
| Catalog Number | 610-1152 |
| 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 | true |
| 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 |
| 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 | |
| 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 | |
| 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 |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| Length | 5.5 Inch |
| Height | 1.1 Inch |
| 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 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436102278 [Package] Contains: 10841436102275 Package: [5 Units] In Commercial Distribution |
| GS1 | 10841436102275 [Primary] |
| IYO | System, imaging, pulsed echo, ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
[00841436102278]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2017-08-22 |
| 00841436102285 | Sterile navigator with (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex™ sensor cov |
| 00841436102278 | Sterile navigator for use with 10-14GA instruments |
| 00841436101882 | Sterile navigator with (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex™ sensor cov |
| 00841436101875 | Sterile navigator for use with 10GA-17GA instruments |
| 00841436101936 | Reusable non-sterile general purpose driveBAY™ , driveBAY™ 2, trakSTAR™ , or trakSTAR™ 2 |
| 00841436100892 | Reusable non-sterile general purpose driveBAY™, trakSTAR™, electromagnetic sensor (8mm) with |
| 20841436121433 | Reusable non-sterile general purpose electromagnetic sensor for use with Aurora trackers with Vi |