Multi-Purpose Workstation™ Stabilizer 610-974

GUDID 00841436104647

Floor Mount

CIVCO MEDICAL INSTRUMENTS CO., INC.

Prostate brachytherapy system applicator, manual

• Primary Device ID: 00841436104647
• NIH Device Record Key: f35a7360-4f23-4075-b11e-2a6dec6a806c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Purpose Workstation™ Stabilizer
• Version Model Number: 610-974
• Catalog Number: 610-974
• 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

• Length: 27.6 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436104647 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-22

Devices Manufactured by CIVCO MEDICAL INSTRUMENTS CO., INC.

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• 20841436125356 - Verza Guidance System: 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with Philips eL 10-2 transduc
• 20841436125516 - Verza Guidance System: 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare L8-18t tra
• 20841436125523 - Needle Guidance System: 2026-01-08 Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA)
• 20841436125530 - Needle Guidance System: 2026-01-08 Reusable non-sterile bracket with AccuSITE™ needle guides (5), and (14x147cm) CIV-Flex™ covers (5) for use with GE Healthca
• 20841436126261 - Verza Guidance System: 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with Samsung CM2-11 transduce
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• 20841436126346 - Tracking Bracket Starter Kit: 2026-01-08 Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison CM1-8 and CM2-11 tr