Cradle 658-006

GUDID 00841436121545

For use with Mindray ELC13-4U/E/s EX3™ Stepper

CIVCO MEDICAL INSTRUMENTS CO., INC.

Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual

• Primary Device ID: 00841436121545
• NIH Device Record Key: 10132a24-20db-4740-8a88-cc28a435e6c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cradle
• Version Model Number: 658-006
• Catalog Number: 658-006
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436121545 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-28

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