FDA UDI
In Commercial Distribution
🇺🇸 United States
Neurolyser XR
DI: 07290019747000
·
Model: NXR100
·
FUSMobile LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Neurolyser XR
- Primary DI
- 07290019747000
- Version / Model
- NXR100
- 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
- c804ac2a-116a-42ed-9c8f-0e9b48abb706
Device Description
The Neurolyser XR is intended for thermal ablation of neural tissue (neurolysis) at the bone tissue interface, using non- invasive high intensity focused ultrasound (HIFU) with X-ray guidance.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| SGN | High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation | Neurology | 882.4420 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66756 | Nerve transcutaneous ultrasound ablation system | An assembly of devices intended to use high intensity focused ultrasound (HIFU) energy to create heat at controlled temperatures for noninvasive (transcutaneous) thermal ablation of neural tissue to treat chronic pain, typically through ablation of medial branch nerves at the bone/neural tissue interface. It is used together with a radiological image-guidance system (e.g., fluoroscopy system) and operating table, and consists of a software-based generator/control unit, imaging workstation, positioning and aiming elements (e.g., mechanical arm, cradle), and an ultrasound transducer/probe intended to be placed on the skin for transcutaneous delivery of focal heat to the target nerve. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290019747000 | GS1 | ||||
| Package | 17290019747007 | GS1 | Box | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN250015 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 57 Degrees Celsius