Sonasource

GUDID 00868108000212

Ultrasonic hyperthermia system

Primary Device ID	00868108000212
NIH Device Record Key	783dc90c-ebde-4407-b7f5-d261d38bfdf3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sonasource
Version Model Number	102-17000-0009
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	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00868108000212 [Primary]

PLP	High Intensity Ultrasound System For Prostate Tissue Ablation

Steralize Prior To Use	false
Device Is Sterile	false

00868108000274 - Sonachill	2020-03-02 System used to regulate temperature and oxygen content of sterile water for a procedure.
00868108000267 - Sonablate Insertion Pack	2019-02-08 A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit
00868108000212 - Sonasource	2018-03-29Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions.
00868108000212 - Sonasource	2018-03-29 Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control Sona
00868108000229 - Sonablate	2018-03-29 Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy.

Mark Image Registration \| Serial	Company Trademark Application Date
SONASOURCE 86018987 4951714 Live/Registered	SonaCare Medical, LLC 2013-07-24