FDA UDI
In Commercial Distribution
🇺🇸 United States
OPERA SWING
DI: 08054890480031
·
Model: STRETCHER
·
GENERAL MEDICAL MERATE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OPERA SWING
- Primary DI
- 08054890480031
- Version / Model
- STRETCHER
- 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
- 98742f21-b323-41fb-adb1-ea9cbbbe3da4
Device Description
The device is a stretcher in carbon fiber and it is raised via an hydraulic piston mechanism which is controlled by a foot-pedal.
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 |
|---|---|---|---|---|
| 15726 | Radiographic stretcher | A manually-operated device consisting of a radiation translucent platform mounted on a wheeled frame designed to transport and support a recumbent patient during the acquisition of radiographic images. It may include various accessories (e.g., slots and cassette-support attachments). It is commonly used in emergencies to produce the first diagnostic images of a patient when there is little time for conventional protocol (e.g., in cases of serious patient trauma or during a large-scale catastrophe). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08054890480031 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140380 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 65 | Centimeter | |
| Length | 210 | Centimeter |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius