AccessGUDID - DEVICE: EXABLATE (07290015461009)

GUDID

Device Identifier (DI) Information

Brand Name: EXABLATE
Version or Model: 2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EXABLATE 2000
Company Name: INSIGHTEC LTD

Primary DI Number: 07290015461009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532169513 *Terms of Use

Device Description: System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS).

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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	An assembly of electrically-powered devices designed to treat solid tumours of soft tissue (e.g., liver, kidney, breast, pancreas, prostate) and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through noninvasive or non-surgically invasive localized application of high intensity focused ultrasound (HIFU) intended to gradually denature/ablate targeted 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 bed; it may be on wheels. Optimal patient positioning is achieved using an ultrasound scanner or a magnetic resonance imaging (MRI) system.

GMDN Preferred Term Name

GMDN Definition

Therapeutic oncological/gynaecological ultrasound system

An assembly of electrically-powered devices designed to treat solid tumours of soft tissue (e.g., liver, kidney, breast, pancreas, prostate) and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through noninvasive or non-surgically invasive localized application of high intensity focused ultrasound (HIFU) intended to gradually denature/ablate targeted 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 bed; it may be on wheels. Optimal patient positioning is achieved using an ultrasound scanner or a magnetic resonance imaging (MRI) system.

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

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Size Type Text
Weight: 890 Kilogram

Device Record Status

Public Device Record Key: 8c976c29-8b55-4122-bb0e-2f1ddd3ad0fb
Public Version Date: December 07, 2018
Public Version Number: 3
DI Record Publish Date: August 03, 2016