TULSA-PRO 109171

GUDID 07540281001370

TULSA-PRO ENDORECTAL COOLING DEVICE

Profound Medical Inc

Therapeutic oncological/gynaecological ultrasound system

• Primary Device ID: 07540281001370
• NIH Device Record Key: 5b77c8f1-e282-4d69-a1a4-4fc1c43dcf07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TULSA-PRO
• Version Model Number: 109171
• Catalog Number: 109171
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	07540281001370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211858

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-03
• Device Publish Date: 2022-09-23

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