Sonasource

GUDID 00868108000212

Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions.

FOCUS SURGERY INC

Ultrasonic hyperthermia system

• Primary Device ID: 00868108000212
• NIH Device Record Key: 783dc90c-ebde-4407-b7f5-d261d38bfdf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonasource
• Version Model Number: 102-17000-0009
• 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	00868108000212 [Primary]

FDA Product Code

• PLP: High Intensity Ultrasound System For Prostate Tissue Ablation

Sterilization

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

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.