Focalpak TMS 239305

GUDID 03661690000069

The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.

EDAP-TMS FRANCE

Physical therapy ultrasound system

• Primary Device ID: 03661690000069
• NIH Device Record Key: fb156e03-9870-411f-a18b-cdbd17b3adf7
• Commercial Distribution Discontinuation: 2019-03-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Focalpak
• Version Model Number: TMS 239305
• Catalog Number: TMS 239305
• Company DUNS: 383113362
• Company Name: EDAP-TMS FRANCE
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661690000069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172721

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: 2023-09-21
• Device Publish Date: 2018-06-11

On-Brand Devices [Focalpak]

• 03661690000243: The Focalpak is the single use kit of consumables to support a single patient procedure using th
• 03661690000069: The Focalpak is the single use kit of consumables to support a single patient procedure using th