Multi-Purpose Workstation™ Kit 638-025

GUDID 00841436105408

Multi-Purpose Workstation™ Stepper and Multi-Purpose Workstation LP for use with Terason 8B4S

CIVCO MEDICAL INSTRUMENTS CO., INC.

Prostate brachytherapy system applicator, manual

• Primary Device ID: 00841436105408
• NIH Device Record Key: db0559f2-e6a1-4408-98fc-57e673b7036c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Purpose Workstation™ Kit
• Version Model Number: 638-025
• Catalog Number: 638-025
• 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

Device Dimensions

• Length: 24.3 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436105408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972672

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

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