DEVICE: EXABLATE (07290015461016)

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Device Identifier (DI) Information

EXABLATE
2100 Type 1.0/1.1/1.11
EXABLATE 2100
INSIGHTEC LTD
07290015461016
GS1
1
System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS). Customer replaceable patient cradle.
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Device Characteristics

MR Safe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Therapeutic oncological/gynaecological ultrasound system, stationary A stationary assembly of mains electricity (AC-powered) devices designed to treat solid tumours of soft tissue (e.g., liver, kidney, breast, pancreas) and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through extracorporeal localized application of high intensity focused ultrasound (HIFU) intended to gradually denature/ablate targeted tissue lesions. It typically consists of a high frequency generator/patient bed/piezoelectric transducer, a water supply/power control unit, operator console and monitoring systems, alarms, software, and possibly a patient hoist. Optimal patient positioning is achieved using an ultrasound scanner or a magnetic resonance imaging (MRI) system.
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FDA Product Code

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Product Code Product Code Name
LSY Ultrasound,Hyperthermia, Cancer Treatment
NRZ Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 0 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 700 and 1060 KiloPascal
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 700 and 1060 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
Weight: 890 Kilogram
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Device Status

In Commercial Distribution
August 03, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
18663922528
info@insightec.com
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