AccessGUDID - DEVICE: ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST 1.5T (07290015461467)

GUDID

Device Identifier (DI) Information

Brand Name: ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST 1.5T
Version or Model: ASC001361-AR ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ASC001361-AR
Company Name: INSIGHTEC LTD

Primary DI Number: 07290015461467
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532169513 *Terms of Use

Device Description: ExAblate 2100V1 LOWER PELVIC COIL for 1.5T GE ARTIST MR guided FUS Body (uterine fibroids, bone mets) treatments

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

[?]

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

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

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Storage Environment Temperature: between -15 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cd53b69c-ea57-444a-9c74-0fd74b2c45bc
Public Version Date: November 08, 2019
Public Version Number: 2
DI Record Publish Date: November 29, 2018