Sonablate Insertion Pack

GUDID 00868108000267

A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit

FOCUS SURGERY INC

Ultrasonic hyperthermia system

• Primary Device ID: 00868108000267
• NIH Device Record Key: 797987a4-3b25-4018-b9b6-84f334183c27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonablate Insertion Pack
• Version Model Number: 403-02200-0014
• 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: true
• 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	00868108000267 [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: 3
• Public Version Date: 2019-02-08
• Device Publish Date: 2017-03-24

On-Brand Devices [Sonablate Insertion Pack]

• 00868108000267: A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit
• 00868108000281: A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit.
• 00850071153095: 403-02200-0002-I
• 00850071153071: 403-02200-0014-I
• 00850071153125: 403-02200-0002-BG