Neurolyser XR 30 mm Gel Pad

Primary DI
07290019747017
Brand
Neurolyser XR 30 mm Gel Pad
Company
FUSMobile LTD
Model
415-00002
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
SGNHigh Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SGNHigh Intensity Focused Ultrasound System For Peripheral Neural Tissue AblationNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN250015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN250015000Neurolyser XR (NXR100)Fusmobile, Inc.2025-11-14SGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019747017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019747017072900197470177290019747017

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound coupling padA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius57 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
531885190
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019747031Neurolyser XR DQA Assembly820-000082025-12-10
07290019747000Neurolyser XRNXR1002025-12-10
07290019747024Neurolyser XR 45 mm Gel Pad 415-000032025-12-10
17290019747038Neurolyser XR DQA Assembly820-000082025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019747031Neurolyser XR DQA AssemblyFUSMobile LTDSGN2025-12-10
07290019747000Neurolyser XRFUSMobile LTDSGN2025-12-10
07290019747024Neurolyser XR 45 mm Gel Pad FUSMobile LTDSGN2025-12-10
17290019747038Neurolyser XR DQA AssemblyFUSMobile LTDSGN2025-12-10