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

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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