AccessGUDID - DEVICE: Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA (07290015461900)

GUDID

Device Identifier (DI) Information

Brand Name: Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA
Version or Model: SET001104 Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SET001104
Company Name: INSIGHTEC LTD

Primary DI Number: 07290015461900
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532169513 *Terms of Use

Device Description: A Kit for 10 Neuro treatments (Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA) Kit content: Part Description SET001047 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) X 2 units

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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
POH	Mr-Guided Focused Ultrasound System

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 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

Public Device Record Key: 3368487e-66fa-477b-9a19-b32b82073623
Public Version Date: June 22, 2023
Public Version Number: 2
DI Record Publish Date: August 10, 2021