Neurolyser XR 30 mm Gel Pad

Basic Information

• Brand Name: Neurolyser XR 30 mm Gel Pad
• Primary DI: 07290019747017
• Version / Model: 415-00002
• Company Name: FUSMobile LTD
• Labeler DUNS: 531885190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-10
• Public Version: 1
• Public Version Date: 2025-12-18
• Public Version Status: New
• Public Device Record Key: a1949641-d35b-43c0-a6b9-cfaf481f8d1d

Device Characteristics

• Single Use: Yes
• 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: 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SGN	High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation	Neurology	882.4420	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66080	Ultrasound coupling pad	A synthetic polymer pad intended for use in noninvasive ultrasound procedures to provide a contact interface between the ultrasound transducer and the patient’s skin, typically used in conjunction with topical coupling gel to improve ultrasound energy transmission. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290019747017	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN250015	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 57 Degrees Celsius