Sonachill

GUDID 00868108000274

System used to regulate temperature and oxygen content of sterile water for a procedure.

FOCUS SURGERY INC

Ultrasonic hyperthermia system

• Primary Device ID: 00868108000274
• NIH Device Record Key: 226ae912-8e3f-40a8-9ff6-27e2726417f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonachill
• Version Model Number: 102-17000-0007
• 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	00868108000274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150011

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: 3
• Public Version Date: 2020-03-02
• Device Publish Date: 2016-09-28

Devices Manufactured by FOCUS SURGERY INC

• 00850071153125 - Sonablate Insertion Pack: 2025-09-29
• 00850071153255 - Sonablate System: 2025-09-01
• 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.