Surgi-Boot Transducer Cover UA0075

GUDID 00841436110372

Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGuard™ tip for use with BK Medical 8809 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

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• Primary Device ID: 00841436110372
• NIH Device Record Key: 971add9c-e554-4a51-a7d4-833ecac8023b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgi-Boot Transducer Cover
• Version Model Number: UA0075
• Catalog Number: UA0075
• 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

Device Dimensions

• Width: 15.2 Inch
• Length: 244 Centimeter
• Width: 15.2 Inch
• Length: 244 Centimeter
• Width: 15.2 Inch
• Length: 244 Centimeter
• Width: 15.2 Inch
• Length: 244 Centimeter
• Width: 15.2 Inch
• Length: 244 Centimeter
• Width: 15.2 Inch
• Length: 244 Centimeter
• Width: 15.2 Inch
• Length: 244 Centimeter
• Width: 15.2 Inch
• Length: 244 Centimeter
• Width: 15.2 Inch
• Length: 244 Centimeter
• Width: 15.2 Inch
• Length: 244 Centimeter

Operating and Storage Conditions

• 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	00841436110372 [Package]; Contains: 10841436110379; Package: [12 Units]; In Commercial Distribution
GS1	10841436110379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013721

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

[00841436110372]

Ethylene Oxide

[00841436110372]

Ethylene Oxide

[00841436110372]

Ethylene Oxide

[00841436110372]

Ethylene Oxide

[00841436110372]

Ethylene Oxide

[00841436110372]

Ethylene Oxide

[00841436110372]

Ethylene Oxide

[00841436110372]

Ethylene Oxide

[00841436110372]

Ethylene Oxide

[00841436110372]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-09-06
• Device Publish Date: 2017-08-22

On-Brand Devices [Surgi-Boot Transducer Cover]

• 00841436110372: Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGu
• 00841436104166: Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGu