Toshiba AccuSITE Bracket 680-135

GUDID 00841436110693

Reusable non-sterile AccuSITE™ bracket for use with Toshiba PLI-2004BX transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, reusable

• Primary Device ID: 00841436110693
• NIH Device Record Key: 051b7372-3f92-4ed7-a6fd-54c77f1eacf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Toshiba AccuSITE Bracket
• Version Model Number: 680-135
• Catalog Number: 680-135
• 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: false
• 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
• 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

Device Dimensions

• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 Inch
• Length: 2.9 Inch
• Width: 1.4 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
• 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	00841436110693 [Primary]
GS1	20841436116712 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093713

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-23
• Device Publish Date: 2017-08-22

Devices Manufactured by CIVCO MEDICAL INSTRUMENTS CO., INC.

• 20841436122881 - Verza Guidance System: 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with Esaote LMX3-16 transduce
• 20841436125356 - Verza Guidance System: 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with Philips eL 10-2 transduc
• 20841436125516 - Verza Guidance System: 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare L8-18t tra
• 20841436125523 - Needle Guidance System: 2026-01-08 Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA)
• 20841436125530 - Needle Guidance System: 2026-01-08 Reusable non-sterile bracket with AccuSITE™ needle guides (5), and (14x147cm) CIV-Flex™ covers (5) for use with GE Healthca
• 20841436126261 - Verza Guidance System: 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with Samsung CM2-11 transduce
• 20841436126339 - Verza Guidance System: 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with Samsung CM1-8 transducer
• 20841436126346 - Tracking Bracket Starter Kit: 2026-01-08 Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison CM1-8 and CM2-11 tr