O-ring Applicator Tool

GUDID 00850071153101

Sonablate HIFU O-ring Applicator Tool. This tool is intended to be included with the Sonablate Insertion Pack and Water Path Kit.

FOCUS SURGERY INC

Invasive ultrasound transducer cooling/coupling support kit

• Primary Device ID: 00850071153101
• NIH Device Record Key: 7ae9968c-8c5b-4579-9932-5d134552fe06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-ring Applicator Tool
• Version Model Number: 302-08119-1002
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850071153101 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-10
• Device Publish Date: 2024-12-02

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.