FDA UDI
In Commercial Distribution
🇺🇸 United States
XR-MX/1000
DI: 07630039101084
·
Model: FD21
·
Storz Medical AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XR-MX/1000
- Primary DI
- 07630039101084
- Version / Model
- FD21
- Catalog Number
- 29483
- Company Name
- Storz Medical AG
- Labeler DUNS
- 481967776
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-08
- Public Version
- 1
- Public Version Date
- 2021-04-16
- Public Version Status
- New
- Public Device Record Key
- e7660a55-0daa-48f1-88cc-2dc1407b921e
Device Description
The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimally invasive urological surgery). The system may be used for urological treatment, planning and diagnostic procedures.
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
- Yes
- 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 |
|---|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37633 | Stationary uro-gynaecological fluoroscopic x-ray system, digital | A stationary diagnostic x-ray system with real-time fluoroscopic capabilities specifically designed for use in urological and/or gynaecological surgical and interventional procedures requiring real-time visualization of the pelvic area. It uses digital techniques for real-time image capture, display and manipulation and include spot-film capabilities as well as fluoroscopic features. It is commonly used for imaging and x-ray guided surgical or interventional procedures. The images can be viewed in both real-time and delayed formats and may include various levels of imaging processing and analysis capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630039101084 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200965 | 000 |