EX3 Stepper 609-004

GUDID 00841436101257

For use with Best® Sonalis™ TRT TriView transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Manual brachytherapy system

• Primary Device ID: 00841436101257
• NIH Device Record Key: 1eceb11f-600d-4135-bd9a-279c5bbd7093
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EX3 Stepper
• Version Model Number: 609-004
• Catalog Number: 609-004
• 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: true
• 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

Device Dimensions

• Length: 44.1 Centimeter
• Length: 15.97 Inch
• Width: 6.21 Inch
• Length: 15.97 Inch
• Width: 6.21 Inch
• Length: 15.97 Inch
• Width: 6.21 Inch
• Length: 15.97 Inch
• Width: 6.21 Inch
• Length: 15.97 Inch
• Width: 6.21 Inch
• Length: 15.97 Inch
• Width: 6.21 Inch
• Length: 15.97 Inch
• Width: 6.21 Inch
• Length: 15.97 Inch
• Width: 6.21 Inch
• Length: 15.97 Inch
• Width: 6.21 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436101257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131161

FDA Product Code

• IWJ: System, applicator, radionuclide, manual

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 [EX3 Stepper]

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• 00841436107396: For use with Siemens Endo-PII transducers
• 00841436105972: For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers
• 00841436105811: For use with GE ERB transducers
• 00841436105392: EX3 Stepper
• 00841436105255: For use with Hitachi Aloka Medical UST-672-5/7.5 transducers
• 00841436101257: For use with Best® Sonalis™ TRT TriView transducers