Scanning Kit EA4015

GUDID 00841436108751

Reusable non-sterile standoff with (2.6 x 30cm) latex covers (10) for use with BK Medical Type 8558 and 8658 7.5 Bi-Plane transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-orifice ultrasound imaging transducer cover, image-enhancement Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover

• Primary Device ID: 00841436108751
• NIH Device Record Key: db12c8e6-41e7-40fb-abb0-be2feabefd88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scanning Kit
• Version Model Number: EA4015
• Catalog Number: EA4015
• 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: true
• 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: 2.6 Centimeter
• Length: 30 Centimeter
• Width: 2.6 Centimeter
• Length: 30 Centimeter
• Width: 2.6 Centimeter
• Length: 30 Centimeter
• Width: 2.6 Centimeter
• Length: 30 Centimeter
• Width: 2.6 Centimeter
• Length: 30 Centimeter
• Width: 2.6 Centimeter
• Length: 30 Centimeter
• Width: 2.6 Centimeter
• Length: 30 Centimeter
• Width: 2.6 Centimeter
• Length: 30 Centimeter
• Width: 2.6 Centimeter
• Length: 30 Centimeter
• Width: 2.6 Centimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436108751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992152

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-22

On-Brand Devices [Scanning Kit]

• 00841436108751: Reusable non-sterile standoff with (2.6 x 30cm) latex covers (10) for use with BK Medical Type 8
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• 00841436103626: Non-sterile extension tube, (60cc) syringe and 3-way stopcock
• 00841436101493: Non-sterile (2.0 x 30cm) NeoGuard™