TopSpin Balloon 689-001

GUDID 10841436107966

Non-sterile latex free endocavity balloon Exclusively for clinical investigations

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use

• Primary Device ID: 10841436107966
• NIH Device Record Key: 6f197a63-ccb5-4aa6-8524-828155712811
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TopSpin Balloon
• Version Model Number: 689-001
• Catalog Number: 689-001
• 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

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
• 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

• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch
• Length: 3.4 Inch
• Height: 1.3 Inch

Operating and Storage Conditions

• 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
• 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	10841436107966 [Primary]

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: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-08-22

Devices Manufactured by CIVCO MEDICAL INSTRUMENTS CO., INC.

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• 00841436122290 - Needle Guide: 2024-06-28 Sterile endocavity needle guide for use with Philips C9-5 ICT and C9-5ec transducers. One-cell MEA: =80% embryo developed to ex