EX3 Stepper 642-443

GUDID 00841436105811

For use with GE ERB transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Prostate brachytherapy system applicator, manual

• Primary Device ID: 00841436105811
• NIH Device Record Key: 7ebbe540-bb2c-4076-a24e-de1d2a369ebd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EX3 Stepper
• Version Model Number: 642-443
• Catalog Number: 642-443
• 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
• Phone: +1(319)248-6502
• Email: regulatory@civco.com

Device Dimensions

• Width: 8.2 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
• Length: 15.97 Inch
• Width: 6.21 Inch
• Length: 15.97 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436105811 [Primary]
GS1	20841436117924 [Direct Marking]

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: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2017-08-22

On-Brand Devices [EX3 Stepper]

• 00841436107839: For use with Terason 8B4S transducers
• 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