Sonablate Insertion Pack

Basic Information

• Brand Name: Sonablate Insertion Pack
• Primary DI: 00868108000281
• Version / Model: 403-02200-0002
• Company Name: FOCUS SURGERY INC
• Labeler DUNS: 101084143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-02
• Public Version: 1
• Public Version Date: 2024-12-10
• Public Version Status: New
• Public Device Record Key: eec50f49-e2d7-49fa-b88c-b6535417232a

Device Description

A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
64000	Invasive ultrasound transducer cooling/coupling support kit	A collection of devices intended to be used in conjunction with a non-surgically invasive ultrasound transducer (probe) (e.g., of a therapeutic oncological/gynaecological ultrasound system) to cool the transducer and improve coupling. It typically consists of a container(s) with fluid (e.g., water with dissolved polymers) which circulates between a heat exchanger and the transducer via connection tubing; it may also include coupling gel and devices intended to detect patient motion during the procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868108000281	GS1