DEVICE: Exablate Neuro Treatment Accessories Kit (07290019402565)
Device Identifier (DI) Information
Exablate Neuro Treatment Accessories Kit
Exablate 4000
In Commercial Distribution
SET004307-ROW
INSIGHTEC LTD
Exablate 4000
In Commercial Distribution
SET004307-ROW
INSIGHTEC LTD
Exablate Neuro Treatment Accessories Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
40781 | Ultrasonic hyperthermia system |
An assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43? Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disease conditions. It is typically computer-controlled and is capable of producing whole-body or localized heating within tissues or organs. Energy delivered to the patient is from either an externally-mounted transducer or a transducer-containing catheter or probe used topically or inserted endoscopically or surgically. Unlike an ultrasound diathermy system, an ultrasound hyperthermia system is not used in physiotherapy applications.
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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 [?] |
---|---|
P150038 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 40 and 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between 5 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d63dffdb-2044-4114-87db-d300c06f1144
May 09, 2025
1
May 01, 2025
May 09, 2025
1
May 01, 2025
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 |
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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