HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)

Basic Information

• Brand Name: HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)
• Primary DI: 07290019402466
• Version / Model: SET400168-AE PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)
• Catalog Number: SET400168-AE
• Company Name: INSIGHTEC LTD
• Labeler DUNS: 532169513
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-26
• Public Version: 1
• Public Version Date: 2023-07-04
• Public Version Status: New
• Public Device Record Key: 922384ab-9b62-4804-9fda-fdf3bfc0c8b5

Device Description

HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment. These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
POH	Mr-Guided Focused Ultrasound System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290019402466	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P150038	023

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius