Water Path Kit

GUDID 00868108000205

Water Path Kit for use with Sonablate HIFU system.

FOCUS SURGERY INC

Invasive ultrasound transducer cooling/coupling support kit

• Primary Device ID: 00868108000205
• NIH Device Record Key: f948906d-a893-4f3f-8e73-32eae395e8d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Water Path Kit
• Version Model Number: E01020AST61
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868108000205 [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: 2024-12-16
• Device Publish Date: 2024-12-07

On-Brand Devices [Water Path Kit]

• 00868108000205: Water Path Kit for use with Sonablate HIFU system.
• 00868108000298: 403-02200-0020
• 00850071153088: 403-02200-0020-I
• 00850071153064: E01020AST61-I