Identity
- Trade Name
- OPERA SWING FDA UDI
- Generic Name
- Radiographic stretcher FDA UDI
- Device Name
- The device is a stretcher in carbon fiber and it is raised via an hydraulic piston mechanism which is controlled by a foot-pedal. FDA UDI
- Model / Reference
- STRETCHER FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054890480031 FDA UDI
- 510(k) Number
- K140380 FDA UDI
- FDA Product Code
- JAA FDA UDI
- GMDN Term
- Radiographic stretcher FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 65 Centimeter FDA UDILength — 210 Centimeter FDA UDI
Category: Radiographic stretcher
Opera Swing by General Medical Merate Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiographic stretcher.
- Prime Series — Stryker Corp. · Class II
- Cogent — FU SHUN HSING TECHNOLOGY CO., LTD. · Class II
- Prime Series — Stryker Corp. · Class II
- Prime Series — Stryker Corp. · Class II
- Cogent — FU SHUN HSING TECHNOLOGY CO., LTD. · Class II
- Prime Series — Stryker Corp. · Class II
- NOA Medical Industries — Hoffmann NOA Medical Industries, LLC · Class II
- Cogent — FU SHUN HSING TECHNOLOGY CO., LTD. · Class II
Cleared under the same submission
K140380 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- General Medical Merate Spa
Sources (1)
- FDA UDI 98742f21-b323-41fb-adb1-ea9cbbbe3da4 36 fields · synced May 30, 2026