| Primary Device ID | 00841436106894 |
| NIH Device Record Key | 539b6341-76f4-42ad-98db-bbd428c032c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tracking Bracket Kit |
| Version Model Number | 667-147 |
| Catalog Number | 667-147 |
| 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 | true |
| 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 |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| Width | 1 Inch |
| Length | 5.3 Inch |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436106894 [Package] Contains: 10841436106891 Package: [24 Units] In Commercial Distribution |
| GS1 | 10841436106891 [Primary] |
| IYO | System, imaging, pulsed echo, ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
[00841436106894]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2017-08-22 |
| 20841436113087 - GUS | 2024-09-17 G14TC-3-EU |
| 20841436122980 - Biopsy Bracket | 2024-09-17 Reusable non-sterile Verza™ bracket for use with FUJIFILM Healthcare MXL65RV and MXL65 transducers |
| 20841436125066 - Biopsy Bracket | 2024-09-17 Reusable non-sterile Verza™ bracket for use with Esaote L 8-24 transducers |
| 20841436122140 - Biopsy Bracket | 2024-06-28 Reusable non-sterile Verza™ bracket for use with Hologic® C9-2X transducers |
| 20841436123284 - Needle Guide Bracket | 2024-06-28 Reusable non-sterile Infiniti Plus™ bracket for use with Siemens HLX transducers |
| 00841436122214 - Needle Guide | 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare E72, E721, EC8, E8C-RS, E8CS, IC5-9-D, IC5-9H, IC9B-RS, MTZ, and MZ t |
| 00841436123051 - Needle Guide | 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare IC9 transducers. One-cell MEA: =80% embryo developed to expand cytob |
| 00841436123068 - Needle Guide | 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare RIC5-9-D, RIC5-9W-RS. RIC6-12-D and Samsung Medison EV3-10B, V5-9 tra |