Cradle 644-084

GUDID 00841436111539

For use with Hitachi Aloka Medical UST-672-5/7.5 Workstation Steppers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Manual brachytherapy system

• Primary Device ID: 00841436111539
• NIH Device Record Key: 60438f43-6879-41e8-9c34-3f4b693bd9e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cradle
• Version Model Number: 644-084
• Catalog Number: 644-084
• 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

Device Dimensions

• Width: 6.5 Centimeter
• Length: 7.7 Centimeter
• Width: 6.5 Centimeter
• Length: 7.7 Centimeter
• Width: 6.5 Centimeter
• Length: 7.7 Centimeter
• Width: 6.5 Centimeter
• Length: 7.7 Centimeter
• Width: 6.5 Centimeter
• Length: 7.7 Centimeter
• Width: 6.5 Centimeter
• Length: 7.7 Centimeter
• Width: 6.5 Centimeter
• Length: 7.7 Centimeter
• Width: 6.5 Centimeter
• Length: 7.7 Centimeter
• Width: 6.5 Centimeter
• Length: 7.7 Centimeter
• Width: 6.5 Centimeter
• Length: 7.7 Centimeter
• Width: 6.5 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
• 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	00841436111539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131161

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-22

On-Brand Devices [Cradle]

• 00841436118545: For use with Sonoscape BCL10-5 Multi-Purpose Workstations Steppers
• 00841436118460: For use with Terason 8BP4 Multi-Purpose Workstation™ Steppers
• 00841436111638: For use with Siemens Endo-PII EXII/EX3 Stepper
• 00841436111621: For use with Siemens Endo-PII Workstation Stepper
• 00841436111560: For use with Hitachi Aloka Medical C41L47RP and EUP-U533 EXII/EX3 Steppers
• 00841436111553: For use with Hitachi Aloka Medical UST-672-5/7.5 EXII/EX3 Steppers
• 00841436111546: For use with Hitachi Aloka Medical EUP-U533 and C41L47RP Workstation Steppers
• 00841436111539: For use with Hitachi Aloka Medical UST-672-5/7.5 Workstation Steppers
• 00841436111515: For use with GE healthcare ERB EXII/EX3 Stepper
• 00841436111508: For use with GE healthcare ERB Workstation Stepper
• 00841436111423: For use with BK Medical 8558, 8658, and 8848 EXII/EX3 Steppers
• 00841436111416: For use with BK Medical 8848 and E14CL4b Workstation Steppers
• 00841436111409: For use with BK Medical 8558, 8658, and 8808 Workstation Steppers
• 00841436111393: For use with BK Medical 8808e and 8818 Workstation Steppers
• 00841436111164: For use with Terason 8B4S EXII/EX3 Stepper
• 00841436111157: For use with Best® Sonalis™ TRT TriView EXII/EX3 Stepper
• 00841436107341: For use with Siemens Endo-P II Classic Stepper
• 00841436105804: For use with GE Healthcare ERB Classic Stepper
• 00841436105347: For use with BK Medical 8658(8558), 8848 and E14CL4b Classic Stepper
• 00841436101240: For use with 3G Ultrasound SimulView Classic Stepper
• 00841436121132: For use with GE E7C8L Steppers
• 00841436121118: For use with GE E7C8L EX3 Stepper
• 00841436121095: For use with GE E7C8L Classic Steppers
• 00841436115124: For use with Mindray 6LB7s Multi-Purpose Workstation Stepper
• 00841436121545: For use with Mindray ELC13-4U/E/s EX3™ Stepper
• 00841436114295: For use with Exact Imaging EV29L Multi-Purpose Workstation™ Stepper