Multi-Purpose Workstation™ Stepper 644-066

GUDID 00841436105842

For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Prostate brachytherapy system applicator, manual

• Primary Device ID: 00841436105842
• NIH Device Record Key: a22d9ff5-7b27-4178-bbfc-8e68def67d6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Purpose Workstation™ Stepper
• Version Model Number: 644-066
• Catalog Number: 644-066
• 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

Device Dimensions

• Width: 12.2 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436105842 [Primary]
GS1	20841436118013 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131161

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

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 [Multi-Purpose Workstation™ Stepper]

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