DEVICE: NEURO PATIENT TREAT.KITS 1.5T MASTER SET for USA (07290015461351)
Device Identifier (DI) Information
NEURO PATIENT TREAT.KITS 1.5T MASTER SET for USA
SET000973 NEURO PATIENT TREAT.KITS 1.5T MASTER SET
In Commercial Distribution
SET000973
INSIGHTEC LTD
SET000973 NEURO PATIENT TREAT.KITS 1.5T MASTER SET
In Commercial Distribution
SET000973
INSIGHTEC LTD
A Kit for 5 Neuro treatment used under 1.5T MRI guidance.
Kit content:
Part Description
SET000937-AA Neuro kit 1.5T US
MPR000444-AA HEAD RING SCREWS LONG SET (sterile)
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
57888 | Therapeutic oncological/gynaecological ultrasound system |
An assembly of electrically-powered devices designed to treat solid tumours of hard (bone) and/or soft tissue [e.g., liver, kidney, breast, prostate] and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through noninvasive or non-surgically invasive localized application of high intensity focused ultrasound (HIFU) or high intensity therapeutic ultrasound (HITU) intended to gradually denature/ablate tissue lesions. It typically consists of a piezoelectric transducer (probe), a water supply/power control unit, operator console and monitoring systems, software, and sometimes a patient table. Optimal patient positioning is achieved using an ultrasound scanner or MRI system.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
POH | Mr-Guided Focused Ultrasound System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 5 and 25 Degrees Celsius |
Storage Environment Temperature: between 5 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3adb9988-296e-4c83-9bb6-59bee9954848
June 22, 2023
4
June 07, 2018
June 22, 2023
4
June 07, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18663922528
info@insightec.com
info@insightec.com