FDA UDI
In Commercial Distribution
🇺🇸 United States
STEPHANIX
DI: 08055186670297
·
Model: OMNISCOP Dream-S
·
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STEPHANIX
- Primary DI
- 08055186670297
- Version / Model
- OMNISCOP Dream-S
- Catalog Number
- 95 01 000
- Company Name
- A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
- Labeler DUNS
- 440069847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-20
- Public Version
- 1
- Public Version Date
- 2021-09-28
- Public Version Status
- New
- Public Device Record Key
- c880accc-aeb0-4bf3-b2d5-63228e0c8a92
Device Description
This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device.
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 |
|---|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | 892.1650 | 2 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37646 | Mobile general-purpose fluoroscopic x-ray system, digital | A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08055186670297 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211777 | 000 |