Primary Device ID | 07540281000243 |
NIH Device Record Key | ba08b895-14a6-4779-8e8a-299a36fbd2a2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sonalleve |
Version Model Number | 451000080776 |
Catalog Number | 451000080776 |
Company DUNS | 243898678 |
Company Name | Profound Medical Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | 07540281000243 [Primary] |
QND | Ablation System, High Intensity Focused Ultrasound (Hifu), Mr Guided, Orthopedic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-14 |
Device Publish Date | 2025-08-06 |
07540281000267 | SONALLEVE MR-HIFU V2 INGENIA 3T |
07540281000250 | SONALLEVE MR-HIFU V2 INGENIA 1.5T |
07540281000243 | SONALLEVE MR-HIFU V2 ACHIEVA 3T |
07540281000236 | SONALLEVE MR-HIFU V2 ACHIEVA 1.5T |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SONALLEVE 79083599 4061938 Live/Registered |
Profound Medical Inc. 2010-03-25 |