TULSA-PRO

GUDID 07540281000069

TULSA-PRO Positioning System Interface Box

Profound Medical Inc

Therapeutic oncological/gynaecological ultrasound system
Primary Device ID07540281000069
NIH Device Record Key37468270-54fc-4706-b474-13180a97fa5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTULSA-PRO
Version Model Number104494
Company DUNS243898678
Company NameProfound Medical Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107540281000069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-10-21

On-Brand Devices [TULSA-PRO]

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

Trademark Results [TULSA-PRO]

Mark Image

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

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