FDA UDI
In Commercial Distribution
🇺🇸 United States
Dornier MedTech
DI: 04049957004118
·
Model: Genesis
·
Dornier MedTech GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dornier MedTech
- Primary DI
- 04049957004118
- Version / Model
- Genesis
- Catalog Number
- K1034269
- Company Name
- Dornier MedTech GmbH
- Labeler DUNS
- 388104085
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-13
- Public Version
- 2
- Public Version Date
- 2024-02-06
- Public Version Status
- Update
- Public Device Record Key
- 934689a2-c416-43d4-bfd4-5df1fe95dcf7
Device Description
Genesis Urology Imaging System, Right, FPD, 80 KW, 480 V
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 |
|---|---|---|---|---|
| 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 | 04049957004118 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122768 | 000 |