AccessGUDID - DEVICE: INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET (07290015461924)

GUDID

Device Identifier (DI) Information

Brand Name: INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET
Version or Model: SET400168-AB INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SET400168-AB
Company Name: INSIGHTEC LTD

Primary DI Number: 07290015461924
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532169513 *Terms of Use

Device Description: INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET. multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment

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
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: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d9d1bec4-4a23-4263-bedc-f31893937dca
Public Version Date: June 22, 2023
Public Version Number: 2
DI Record Publish Date: August 10, 2021