FDA UDI
In Commercial Distribution
🇺🇸 United States
Neurolyser XR DQA Assembly
DI: 07290019747031
·
Model: 820-00008
·
FUSMobile LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Neurolyser XR DQA Assembly
- Primary DI
- 07290019747031
- Version / Model
- 820-00008
- 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
- 612e00d9-785f-4eca-a86e-86e0f03c3664
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 40620 | Fluoroscopic x-ray phantom, test object | A device that consist of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of fluoroscopic x-ray systems and associated image display systems, image acquisition software, and related system and application software programs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290019747038 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 07290019747031 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN250015 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 27 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Don't expose to sunlight