AccessGUDID - DEVICE: Gel Pad ASSY (07290015461085)

GUDID

Device Identifier (DI) Information

Brand Name: Gel Pad ASSY
Version or Model: Gel Pad ASSY
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SET999014
Company Name: INSIGHTEC LTD

Primary DI Number: 07290015461085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532169513 *Terms of Use

Device Description: Transmission gel pad for single Body treatment. shipped in the following thickness (height) variants: Description Catalogue Number GEL PAD UF 25MM ASSY ASM000352-AA GEL PAD 15MM ASSY ASM000830-AA GEL PAD 40MM ASSY(Step) ASM002213 GEL PAD 45MM ASSY(Bowl) ASM000504-AA

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):	No
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
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

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 25 Degrees Celsius
Handling Environment Temperature: between 5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 45 Millimeter
Height: 40 Millimeter
Height: 25 Millimeter
Height: 15 Millimeter

Device Record Status

Public Device Record Key: 22548ae2-0d04-48fd-8b1d-a689c96806c7
Public Version Date: November 08, 2019
Public Version Number: 4
DI Record Publish Date: June 07, 2017