Verza Guidance System 11504106

GUDID 20841436120528

Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5), and cleaning brushes (5) for use with Siemens Healthineer 14L4 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Ultrasound imaging system tracking holder, reusable

• Primary Device ID: 20841436120528
• NIH Device Record Key: 0eaf19d3-b436-49a7-86d2-9f8056d55582
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verza Guidance System
• Version Model Number: 11504106
• Catalog Number: 11504106
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com

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
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436120548 [Primary]
GS1	00841436121569 [Primary]
GS1	20841436120528 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160806

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-05
• Device Publish Date: 2022-04-27

On-Brand Devices [Verza Guidance System]

• 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)
• 00841436111911: Reusable non-sterile Verza™ bracket for use with Canon Medical SystemsPL1-705BX(i11LX3) transd
• 00841436111904: Reusable non-sterile bracket with Verza™ guides (5) and (14x91.5cm) CIV-Flex™ covers(5) for
• 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)