Sonablate

GUDID 00868108000229

Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy.

FOCUS SURGERY INC

Ultrasonic hyperthermia system

• Primary Device ID: 00868108000229
• NIH Device Record Key: 028284e2-f7fc-49e7-8375-857cec7c94e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonablate
• Version Model Number: 202-17000-0012
• Company DUNS: 101084143
• Company Name: FOCUS SURGERY 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868108000229 [Primary]

FDA Product Code

• PLP: High Intensity Ultrasound System For Prostate Tissue Ablation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00868108000229]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-03-24

Devices Manufactured by FOCUS SURGERY INC

• 00850071153064 - Water Path Kit: 2024-12-17
• 00850071153071 - Sonablate Insertion Pack: 2024-12-17
• 00850071153088 - Water Path Kit: 2024-12-17
• 00850071153095 - Sonablate Insertion Pack: 2024-12-17
• 00868108000298 - Water Path Kit: 2024-12-17
• 00868108000205 - Water Path Kit: 2024-12-16 Water Path Kit for use with Sonablate HIFU system.
• 00850071153101 - O-ring Applicator Tool: 2024-12-10 Sonablate HIFU O-ring Applicator Tool. This tool is intended to be included with the Sonablate Insertion Pack and Water Path Kit
• 00868108000281 - Sonablate Insertion Pack: 2024-12-10 A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit.