| Primary Device ID | 00841436110464 |
| NIH Device Record Key | b9cbccaf-bdbb-4579-a7df-29ac59ec8559 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Verza Guidance System |
| Version Model Number | 610-1500 |
| Catalog Number | 610-1500 |
| Company DUNS | 134614411 |
| Company Name | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| Device Count | 24 |
| 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 |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 Inch |
| Width | 1.32 Inch |
| Length | 1.05 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 |
| 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 | 00841436110464 [Primary] |
| GS1 | 80841436110460 [Unit of Use] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
[00841436110464]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-22 |
| 00841436118767 | Ultrasound guide for use with VerzaLink™ enabled transducers and brackets with (14 × 147cm) t |
| 00841436118231 | Ultrasound guide for use with VerzaLink™ enabled transducers and brackets with (14 × 147cm) t |
| 20841436118877 | Reusable non-sterile bracket with Verza guides (5) and (14 x 91.5cm) CIV-Flex covers (5) for use |
| 20841436115654 | Reusable non-sterile Verza™ bracket for use with GE Healthcare C1-6 transducers |
| 20841436115579 | Reusable non-sterile bracket with Verza™ guides (5) and (14 × 91.5cm) CIV-Flex™ covers (5) |
| 20841436115364 | Reusable non-sterile bracket with Verza™ guides (5) and (14 × 91.5cm) CIV-Flex™ covers (5) |
| 20841436115326 | Reusable non-sterile bracket with Verza™ guides (5) and (14 × 91.5cm) CIV-Flex™ covers (5) |
| 20841436115340 | Reusable non-sterile bracket with Verza™ guides (5) and (14 × 91.5cm) CIV-Flex™ covers (5) |
| 20841436115562 | Reusable non-sterile bracket with Verza™ guides (5) and (14 × 91.5cm) CIV-Flex™ covers (5) |
| 20841436115432 | Reusable non-sterile bracket with Verza™ guides (5) and (14 × 91.5cm) CIV-Flex™ covers (5) |
| 00841436110563 | Reusable non-sterile bracket with Verza™ guides (5) and (14 × 91.5cm) CIV-Flex™ covers (5) |
| 00841436110556 | Reusable non-sterile bracket with Verza™ guides (5) and (14 × 91.5cm) CIV-Flex™ covers (5) |
| 00841436110488 | Ultrasound guide for use with VerzaLink™ enabled transducers and brackets with (14 × 91.5cm) |
| 00841436110464 | Ultrasound guide for use with VerzaLink™ enabled transducers and brackets with (14 × 91.5cm) |
| 80841436112181 | Reusable non-strile bracket with Verza™ guides(5) and (14x91.5cm) CIV-Flex™ covers(5) for us |
| 00841436119979 | Reusable non-sterile bracket Samsung CA1-7S transducers |
| 00841436119849 | Reusable non-sterile Verza™ bracket for use with Hitachi C23 and C23RV transducers |
| 00841436114608 | Reusable non-sterile bracket with Verza™ guides (5) and (14x91.5cm) CIV-Flex™ covers (5) for |
| 00841436114363 | Reusable non-sterile bracket with Verza™ guides (5) and (14x91.5cm) CIV-Flex™ covers (5) for |
| 00841436114356 | Reusable non-sterile Verza™ bracket for use with Cano Medical Systems PVT-574BT(10C1) transduc |
| 00841436114349 | Reusable non-sterile bracket with Verza™ guides (5) and (14x91.5cm) CIV-Flex™ covers(5) for |
| 00841436114332 | Reusable non-sterile Verza™ bracket for use with Canon Medical Systems PV1-574BX(i10CX1) trans |
| 00841436114325 | Reusable non-sterile bracket with Verza™ guides (5) and (14x91.5) CIV-Flex™ covers (5) for u |
| 00841436113632 | Reusable non-sterile bracket with Verza™ guides(5) and (14x91.5cm) CIV-Flex covers for use wit |
| 00841436112314 | Reusable non-sterile Verza™ bracket for use with Canon Medical Systems 11L4/18L7 transducers |
| 00841436112307 | Reusable non-sterile bracket with Verza™ guides (5) and (14x91.5cm) CIV-Flex™ covers(5) for |
| 00841436112291 | Reusable non-sterile Verza™ bracket for use with Canon Medical Systems 6C2 transducers |
| 00841436112284 | Reusable non-sterile bracket with Verza™ guides (5) and (14x91.5cm) CIV-Flex™ covers(5) for |
| 00841436112215 | Reusable non-sterile Verza™ bracket for use with Siemens Healthineers 14L5(Model No. 11254090) |
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| 00841436111782 | Reusable non-sterile Verza™ bracket for use with Canon Medical Systems PS1-30YX(i6sVX1) and PS |
| 00841436111775 | Reusable non-sterile bracket with Verza guides (5) and (14 x 91.5cm) CIV-Flex covers (5) for use |
| 00841436120937 | Reusable non-sterile bracket for use with GE ML4-20 transducers |
| 00841436120920 | Reusable non-sterile bracket with Verza guides (5) and (14 x 91.5cm) CIV-Flex covers (5) for use |
| 00841436119917 | Reusable non-sterile bracket with Verza guides (5) and (14x91.5cm) CIV-Flex™ covers (5), for |
| 00841436119481 | Reusable non-sterile bracket for use with Siemens 7L2 transducers |
| 00841436119474 | Reusable non-sterile bracket with Verza guides (5) and (14 x 91.5cm) CIV-Flex covers (5) for use |
| 00841436121361 | Reusable non-sterile bracket with Verza guides (5) and (14x91.5cm) CIV-Flex™ covers (5), for |
| 00841436121286 | Reusable non-sterile Verza bracket for use with Samsung Medison PA1-5A transducers |
| 00841436121279 | Reusable non-sterile bracket with Verza guides (5) and (14x91.5cm) CIV-Flex™ covers (5), for |
| 00841436120579 | Reusable non-sterile Verza bracket for use with GE L4-20t transducers |
| 20841436118389 | Reusable non-sterile tracking bracket with Verza™ guides (5), (14 x 91.5cm) CIV-Flex™ covers |
| 20841436115777 | Reusable non-sterile tracking bracket with Verza™ guides (5), (14 x 91.5cm) CIV-Flex™ covers |
| 20841436115739 | Reusable non-sterile tracking bracket with Verza™ guides (5), (14 x 91.5cm) CIV-Flex™ covers |
| 00841436112185 | Reusable non-sterile bracket with Verza™ guides (5) and (14x91.5cm) CIV-Flex™ covers (5), f |
| 00841436118774 | Ultrasound guide for use with VerzaLink™ enabled transducers and brackets with (14 × 147cm) t |
| 00841436119962 | Reusable non-sterile bracket with Verza guides (5) and (14 x 91.5cm) CIV-Flex covers (5) for use |
| 00841436119832 | Reusable non-sterile bracket with Verza™ guides (5) and (8.9 x 91.5cm) CIV-Flex™ covers (5) |
| 00841436113670 | Ultrasound guide for use with VerzaLink™ enabled transducers and brackets with (8.9 × 91.5cm) |