FDA UDI
In Commercial Distribution
🇺🇸 United States
OPERA SWING
DI: 08054890480017
·
Model: X-RAY REMOTE TABLE OPERA SWING
·
GENERAL MEDICAL MERATE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OPERA SWING
- Primary DI
- 08054890480017
- Version / Model
- X-RAY REMOTE TABLE OPERA SWING
- Company Name
- GENERAL MEDICAL MERATE SPA
- Labeler DUNS
- 428658934
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2019-04-10
- Public Version Status
- Update
- Public Device Record Key
- 7a079fb6-da3d-4f67-b4c0-aec354c5e397
Device Description
The device is a R&F remote tilting table which allows the execution of longitudinal, trasversal and oblique scanning and lateral projections without moving the patient. It is made by carbon fiber.
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 |
|---|---|---|---|---|
| KXJ | Table, Radiologic | Radiology | 892.1980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40658 | Fluoroscopy/angiography table, powered | A powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08054890480017 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140380 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 65 | Centimeter | |
| Length | 240 | Centimeter |