TULSA-PRO

GUDID 07540281000113

Cable - UA to PSIB, 128MHz

Profound Medical Inc

Therapeutic oncological/gynaecological ultrasound system

Primary Device ID	07540281000113
NIH Device Record Key	d81b0030-2665-4399-9c75-ae6cd6a9867b
Commercial Distribution Status	In Commercial Distribution
Brand Name	TULSA-PRO
Version Model Number	105486
Company DUNS	243898678
Company Name	Profound Medical Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
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 Identifiers

Device Issuing Agency	Device ID
GS1	07540281000113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191200

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	2
Public Version Date	2019-11-08
Device Publish Date	2019-10-21

On-Brand Devices [TULSA-PRO]

07540281000182	TULSA-PRO Tube-set - Endorectal Cooling Device
07540281000175	TULSA-PRO Tube-set Ultrasound Applicator
07540281000168	TULSA-PRO Endorectal Cooling Device
07540281000151	TULSA-PRO Ultrasound Applicator
07540281000113	Cable - UA to PSIB, 128MHz
07540281000106	Cable - UA to PSIB, 123MHz
07540281000090	Cable - FB to PSIB, 40 FT
07540281000083	Cable - SE to FB, 25FT
07540281000076	TULSA-PRO Treatment Delivery Console
07540281000069	TULSA-PRO Positioning System Interface Box
07540281000052	TULSA-PRO Filter Box
07540281000045	TULSA-PRO System Cart
07540281000038	TULSA-PRO Positioning System
07540281000021	TULSA-PRO System Electronics
07540281000014	TULSA-PRO System
07540281000212	TULSA-PRO Disposable Kit
07540281000922	Cable - UA to PSIB 3T Siemens
07540281000915	Cable – UA to PSIB, 1.5T Siemens
07540281000892	Cable – PS to PSIB,1.5T
07540281000885	CABLE – PS to PSIB, 3.0T
07540281000878	Cable - FB to PSIB, 40 FT
07540281000861	Cable - UA to PSIB, 3T Philips
07540281000144	TULSA-PRO Positioning System Interface Box
07540281000137	TULSA-PRO Filter Box
07540281000120	TULSA-PRO Positioning System
07540281001295	DISPOSABLE KIT
07540281001301	TULSA-PRO® MAGNET KIT – Philips Ingenia 1.5T
07540281001288	TULSA-PRO® MAGNET KIT – SIEMENS BED 515.7mm PITCH (SOLA)
07540281001240	TULSA-PRO® MAGNET KIT – SIEMENS BED 511.5mm PITCH
07540281001233	TULSA-PRO® MAGNET KIT – SIEMENS BED 518.5mm PITCH
07540281001196	TULSA-PRO® MAGNET KIT – SKYRA
07540281000908	Cable- UA to PSIB 1.5T Philips 63.87 MHZ
07540281000847	TULSA-PRO® MAGNET KIT – INGENUITY
07540281000830	TULSA-PRO® MAGNET KIT – INGENIA
07540281000823	TULSA-PRO® MAGNET KIT – PRISMA
07540281000816	TULSA-PRO® MAGNET KIT – ACHIEVA
07540281001400	TULSA-PRO DISPOSABLE KIT
07540281001370	TULSA-PRO ENDORECTAL COOLING DEVICE
07540281001615	CABLE - UA TO PSIB, 123 MHz
07540281001691	TULSA-PRO ULTRASOUND APPLICATOR
07540281001684	TULSA-PRO TUBE-SET - ENDORECTAL COOLING DEVICE
07540281001677	TULSA-PRO TUBE-SET - ULTRASOUND APPLICATOR
07540281001660	TULSA-PRO POSITIONING SYSTEM
07540281001653	TULSA-PRO POSITIONING SYSTEM
07540281001646	TULSA-PRO Positioning System Interface Box
07540281001639	TULSA-PRO Positioning System Interface Box
07540281001608	CABLE - UA TO PSIB 1.5T SIEMENS
07540281001592	CABLE - UA TO PSIB 3.0T SIEMENS
07540281001585	CABLE - UA TO PSIB 3.0T PHILIPS & GE
07540281001578	Cable - PS to PSIB, 1.5T

Trademark Results [TULSA-PRO]

Mark Image Registration \| Serial	Company Trademark Application Date
TULSA-PRO 86414439 5362232 Live/Registered	Profound Medical Inc. 2014-10-03